| SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K033522) | Trek Diagnostic Systems, Inc. | 2004-02-03 |
| DUOPATH VEROTOXINS GLISA TEST (K031367) | Emd Chemicals, Inc. | 2004-01-23 |
| IDEIA PCE CHLAMYDIA (K033865) | Dakocytomation, Ltd. | 2004-01-21 |
| MODIFICATION TO SERAQUEST EB VCA IGG (K033915) | Quest Intl., Inc. | 2004-01-16 |
| MODIFICATION TO SERAQUEST VCA IGM (K033780) | Quest Intl., Inc. | 2004-01-15 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS (K033560) | Becton, Dickinson & CO | 2004-01-14 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE (K033557) | Becton, Dickinson & CO | 2004-01-14 |
| GEN-PROBE APTIMA COMBO 2 ASSAY (K032554) | Gen-Probe, Inc. | 2003-12-31 |
| TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS (K032194) | Gen-Probe, Inc. | 2003-12-24 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS (K033558) | Becton, Dickinson & CO | 2003-12-19 |
| REDLINE ANTHRAX ALERT TEST (K030370) | Tetracore, Inc. | 2003-12-09 |
| IMMUNOCARDSTAT HPSA (K032222) | Meridian Bioscience, Inc. | 2003-12-05 |
| BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (K033070) | Trinity Biotech USA | 2003-11-26 |
| LEGIONELLA PNEUMOPHILA IGG/IGM (K033051) | Trinity Biotech USA | 2003-11-26 |
| MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) (K033482) | Dade Behring, Inc. | 2003-11-26 |
| HERPES GROUP IGG (K033059) | Trinity Biotech, Inc. | 2003-11-26 |
| MYCOPLASMA IGG (K033064) | Trinity Biotech USA | 2003-11-26 |
| CHLAMYDIA IGG ELISA TEST SYSTEM (K033079) | Trinity Biotech USA | 2003-11-26 |
| BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (K033083) | Trinity Biotech USA | 2003-11-26 |
| PYLORI IGG (K033067) | Trinity Biotech USA | 2003-11-26 |
| BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG (K032713) | Boston Biomedica, Inc. | 2003-11-24 |
| XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (K031942) | Remel, Inc. | 2003-11-18 |
| PASCO MIC AND MIC/ID PANELS (K033119) | Pasco Laboratories, Inc. | 2003-11-18 |
| XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (K031965) | Remel, Inc. | 2003-11-14 |
| VITEK 2 GRAM NEGATIVE MOXIFLOXACIN (K032861) | bioMerieux, Inc. | 2003-11-12 |
| XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (K031834) | Remel, Inc. | 2003-11-10 |
| GIARDIA II (K033274) | Techlab, Inc. | 2003-11-04 |
| VITEK 2 GRAM NEGATIVE GATIFLOXACIN (K032788) | bioMerieux, Inc. | 2003-11-04 |
| VITEK 2 GRAM POSITIVE LINEZOLID (K032766) | bioMerieux, Inc. | 2003-10-31 |
| VITEK GRAM NEGATIVE GATIFLOXACIN (K032711) | bioMerieux, Inc. | 2003-10-31 |
| VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN (K032738) | bioMerieux, Inc. | 2003-10-31 |
| WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (K031952) | Focus Technologies, Inc. | 2003-10-22 |
| WEST NILE VIRUS ELISA IGG, MODEL EL0300G (K031953) | Focus Technologies, Inc. | 2003-10-22 |
| BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 (K032166) | Binax, Inc. | 2003-10-21 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML (K032655) | Becton, Dickinson & CO | 2003-10-06 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS (K032275) | Becton, Dickinson & CO | 2003-09-29 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML (K032299) | Becton, Dickinson & CO | 2003-09-22 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE (K032567) | Becton, Dickinson & CO | 2003-09-17 |
| PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) (K032518) | Bd Diagnostic Systems | 2003-09-15 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML (K032153) | Bd Diagnostic Systems | 2003-09-11 |
| QUICKVUE INFLUENZA A+B TEST (K031899) | Quidel Corp. | 2003-09-11 |
| VITEK 2 GRAM POSITIVE MOXIFLOXACIN (K032399) | bioMerieux, Inc. | 2003-09-10 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K032382) | Trek Diagnostic Systems, Inc. | 2003-08-29 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML (K031984) | Becton, Dickinson & CO | 2003-08-27 |
| VITEK 2 GRAM POSITIVE GATIFLOXACIN (K032314) | bioMerieux, Inc. | 2003-08-22 |
| VERSATREK (K032306) | Trek Diagnostic Systems, Inc. | 2003-08-22 |
| PASCO MIC AND MIC/ID PANELS (K032259) | Bd Diagnostic Systems | 2003-08-19 |
| BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS (K032131) | Becton, Dickinson & CO | 2003-08-18 |
| VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE (K031865) | bioMerieux, Inc. | 2003-08-13 |
| MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (K032246) | Starplex Scientific, Inc. | 2003-08-13 |
| ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY (K032162) | Beckman Coulter, Inc. | 2003-08-08 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML (K031943) | Becton, Dickinson & CO | 2003-08-06 |
| MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML) (K031602) | Dade Behring, Inc. | 2003-07-31 |
| PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (K031727) | Pasco Laboratories, Inc. | 2003-07-30 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML (K031699) | Becton, Dickinson & CO | 2003-07-30 |
| BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML (K031912) | Becton, Dickinson & CO | 2003-07-21 |
| XPECT INFLUENZA A/B (K031565) | Remel, Inc. | 2003-07-17 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE (K031545) | Trek Diagnostic Systems, Inc. | 2003-07-16 |
| BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM (K031679) | Becton, Dickinson & CO | 2003-07-16 |
| RUBELLACOL (K031490) | Immunostics Inc., | 2003-07-16 |
| BACT/ALERT MP CULTURE BOTTLES (PLASTIC) (K031737) | bioMerieux, Inc. | 2003-07-14 |
| ACON STREP A RAPID TEST DEVICE (K031784) | ACON Laboratories, Inc. | 2003-07-14 |
| C. DIFF CHEK - 60 (K030992) | Techlab, Inc. | 2003-07-11 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE (K031589) | Becton, Dickinson & CO | 2003-07-11 |
| C. DIFF CHEK - 30 (K030991) | Techlab, Inc. | 2003-07-11 |
| VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE (K031410) | bioMerieux, Inc. | 2003-07-10 |
| IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 (K031059) | Ivd Research, Inc. | 2003-07-10 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML (K031530) | Becton, Dickinson & CO | 2003-07-10 |
| WEST NILE VIRUS IGM CAPTURE ELISA (DEN030004) | Panbio Limited | 2003-07-08 |
| EBV VCA-P18 IGG ELISA (K030863) | Panbio Limited | 2003-06-27 |
| ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY (K031606) | Beckman Coulter, Inc. | 2003-06-20 |
| ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE (DEN030002) | Spectral Diagnostics, Inc. | 2003-06-16 |
| PASCO MIC AND MIC/ID PANELS (K031205) | Pasco Laboratories, Inc. | 2003-06-13 |
| PASCO MIC AND MIC/ID PANELS (ERTAPENEM) (K031103) | Pasco Laboratories, Inc. | 2003-06-12 |
| INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST (K024360) | Alfa Scientific Designs, Inc. | 2003-06-10 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML (K031429) | Bd Diagnostic Systems | 2003-06-06 |
| ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY (K031506) | Beckman Coulter, Inc. | 2003-06-02 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE (K031306) | Becton, Dickinson & CO | 2003-06-02 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML (K030986) | Becton, Dickinson & CO | 2003-05-16 |
| PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 (K023857) | Bio-Rad | 2003-05-16 |
| KALAZAR DETECT (K023483) | Inbios Intl., Inc. | 2003-05-06 |
| PASCO MIC AND MIC/ID PANELS (K030933) | Pasco Laboratories, Inc. | 2003-05-01 |
| C. DIFFICILE TOX A/B II (K030404) | Techlab, Inc. | 2003-04-24 |
| GC OIA (K023947) | Thermo Biostar, Inc. | 2003-04-17 |
| PASCO MIC AND MIC/ID PANELS (K030620) | Pasco Laboratories, Inc. | 2003-04-14 |
| URINE MONOVETTE BORIC ACID (K024237) | Sarstedt, Inc. | 2003-04-14 |
| ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE (K024350) | ACON Laboratories, Inc. | 2003-04-02 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE (K030677) | Becton, Dickinson & CO | 2003-04-01 |
| QUANTA LITE H.PYLORI IGA ELISA (K024334) | Inova Diagnostics, Inc. | 2003-03-27 |
| FLU OIA A/B TEST KIT (K023556) | Thermo Biostar, Inc. | 2003-03-27 |
| BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS (K024240) | Bd | 2003-03-26 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML (K030579) | Becton, Dickinson & CO | 2003-03-21 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K024357) | Trek Diagnostic Systems, Inc. | 2003-03-17 |
| SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K024353) | Trek Diagnostic Systems, Inc. | 2003-03-06 |
| IVD CRYPTO/GIARDIA DFA (K024113) | Ivd Research, Inc. | 2003-03-05 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML (K030091) | Bd Diagnostic Systems | 2003-02-28 |
| XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 (K020595) | Xenotope Diagnostics, Inc. | 2003-02-20 |
| ACON STREP A TWIST TEST DEVICE (K023766) | Acon Laboratories Co. | 2003-02-10 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML (K024153) | Becton, Dickinson & CO | 2003-02-10 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML (K024152) | Becton, Dickinson & CO | 2003-01-31 |