| URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM (K013819) | Sierra Diagnostic, LLC | 2002-02-28 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K014258) | Trek Diagnostic Systems, Inc. | 2002-02-19 |
| MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML) (K020328) | Dade Behring, Inc. | 2002-02-19 |
| PYLORITEK VP TEST KIT 5140VP (K014038) | Serim Research Corp. | 2002-02-08 |
| MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML) (K020185) | Dade Behring, Inc. | 2002-02-06 |
| MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML) (K020249) | Dade Behring, Inc. | 2002-02-06 |
| MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML) (K020209) | Dade Behring, Inc. | 2002-02-06 |
| MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML) (K020246) | Dade Behring, Inc. | 2002-02-06 |
| MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML) (K020182) | Dade Behring, Inc. | 2002-02-06 |
| MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML) (K020173) | Dade Behring, Inc. | 2002-02-06 |
| MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) (K020168) | Dade Behring, Inc. | 2002-02-06 |
| CAPTIAM SYPHILIS-G ASSAY (K014233) | Trinity Biotech, Plc | 2002-01-24 |
| BREATHTEK - UBIT UBT FOR H. PYLORI (K014225) | Meretek Diagnostics, Inc. | 2002-01-17 |
| IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 (K012075) | Diagnostic Products Corp. | 2002-01-10 |
| IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 (K012077) | Diagnostic Products Corp. | 2002-01-10 |
| BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY (K012183) | Bayer Diagnostics Corp. | 2001-12-27 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES (K013925) | Trek Diagnostic Systems, Inc. | 2001-12-21 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE (K013580) | Trek Diagnostic Systems, Inc. | 2001-12-12 |
| SAS STREPALERT (K013379) | Sa Scientific, Inc. | 2001-12-12 |
| MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS (K013423) | Dade Microscan, Inc. | 2001-12-12 |
| OXOID PYLORI TEST KIT, MODEL DR0130M (K012588) | Oxoid , Ltd. | 2001-12-10 |
| OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (K011043) | Osmetech | 2001-11-30 |
| BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST (K012521) | Binax, Inc. | 2001-11-30 |
| INFLUENZA A/B RAPID TEST, CAT NO 2158 663 (K011684) | Roche Diagnostics Corp. | 2001-11-30 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K013075) | Trek Diagnostic Systems, Inc. | 2001-11-26 |
| BACTI-SWAB DRY (K013711) | Remel Co. | 2001-11-26 |
| HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K013368) | Trek Diagnostic Systems, Inc. | 2001-11-20 |
| UNI-GOLD STREP A TEST KIT (K011709) | Trinity Biotech, Plc | 2001-11-08 |
| HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES (K013195) | Trek Diagnostic Systems, Inc. | 2001-11-07 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K012921) | Trek Diagnostic Systems, Inc. | 2001-11-02 |
| HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (K012895) | Trek Diagnostic Systems, Inc. | 2001-10-30 |
| MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST (K991810) | Trek Diagnostic Systems, Inc. | 2001-10-09 |
| HP-ONE (K012411) | Gi Supply | 2001-09-25 |
| MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 (K010891) | Digene Corp. | 2001-09-25 |
| MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (K010892) | Digene Corp. | 2001-09-24 |
| MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 (K010893) | Digene Corp. | 2001-09-24 |
| BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY (K012351) | Becton, Dickinson & CO | 2001-09-18 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K012565) | Trek Diagnostic Systems, Inc. | 2001-09-12 |
| HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K012151) | Trek Diagnostic Systems, Inc. | 2001-08-29 |
| DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K010418) | Dade Behring, Inc. | 2001-08-22 |
| BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY (K010755) | Bayer Corp. | 2001-08-20 |
| SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES (K011803) | Trek Diagnostic Systems, Inc. | 2001-08-15 |
| COPAN VIRAL TRANSYSTEM (K001780) | Copan Diagnostics, Inc. | 2001-07-31 |
| DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K010159) | Dade Microscan, Inc. | 2001-07-27 |
| VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI (K011668) | Oridion Medical 1987 , Ltd. | 2001-07-09 |
| BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY (K010668) | Bayer Corp. | 2001-07-05 |
| HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 (K011384) | Hardy Diagnostics | 2001-06-13 |
| ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 (K003259) | Beckman Coulter, Inc. | 2001-06-13 |
| IMMUNOWELL EA (D) IGG TEST (K010301) | Genbio | 2001-06-11 |
| BACTEC MGIT 960 SIR KITS (K003062) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-06-06 |
| NAT - NUCLEIC ACID TRANSPORT (K003761) | Medical Packaging Corp. | 2001-05-31 |
| VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION (K010858) | Id Biomedical Corp. | 2001-05-24 |
| GEN-PROBE APTIMA COMBO 2 ASSAY (K003395) | Gen-Probe, Inc. | 2001-05-21 |
| HARDKYDISK NEOMYCIN, 30 MCG (K011385) | Hardy Diagnostics | 2001-05-18 |
| IMMUNETICS C6 LYME ELISA KIT (K003754) | Immunetics, Inc. | 2001-05-10 |
| QUICKVUE DIPSTICK STREP A (K011097) | Quidel Corp. | 2001-05-08 |
| ACON STREP A RAPID TEST STRIP (K010582) | Acon Laboratories Co. | 2001-05-07 |
| HARDYDISK BACITRACIN, 10MCG, MODEL Z927 (K011086) | Hardy Diagnostics | 2001-04-26 |
| PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST (K011116) | Pasco Laboratories, Inc. | 2001-04-24 |
| MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K010536) | Oxoid , Ltd. | 2001-04-24 |
| LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K010537) | Oxoid , Ltd. | 2001-04-24 |
| PASCO MIC AND MIC/ID PANELS (K010508) | Pasco Laboratories, Inc. | 2001-04-23 |
| MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 (K010878) | Diagnostic Products Corp. | 2001-04-18 |
| ADVIA CENTAUR RUBELLA IGG ASSAY (K003412) | Bayer Corp. | 2001-04-13 |
| ETEST MEROPENEM (K010363) | Ab Biodisk | 2001-04-09 |
| ELISA TEST, SEROLOGY (K003794) | Micro Detect, Inc. | 2001-03-30 |
| MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (K010523) | Binax, Inc. | 2001-03-15 |
| SUSCEPTIBILITY TEST PANEL (K004045) | Trek Diagnostic Systems, Inc. | 2001-03-06 |
| SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS (K003868) | Trek Diagnostic Systems, Inc. | 2001-02-27 |
| SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS (K003834) | Trek Diagnostic Systems, Inc. | 2001-02-23 |
| HARDYDISK SULFISOXAZOLE (K003690) | Hardy Diagnostics | 2001-01-25 |
| BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY (K000884) | Becton Dickinson Biosciences | 2001-01-19 |
| HARDYDISK TRIMETHOPRIM 5MCG (K003554) | Hardy Diagnostics | 2001-01-19 |
| HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG (K003556) | Hardy Diagnostics | 2001-01-17 |
| HARDYDISK NAFCILLIN, 1 MCG (K003536) | Hardy Diagnostics | 2001-01-12 |
| HARDYDISK RIFAMPIN, 5MCG (K003537) | Hardy Diagnostics | 2001-01-12 |
| HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG (K003686) | Hardy Diagnostics | 2001-01-12 |
| DRIED GRAM-POSITIVE MIC/COMBO PANELS (K003619) | Dade Microscan, Inc. | 2001-01-09 |
| HARDY DISK, CEFPODOXINE, 10MCG (K003532) | Hardy Diagnostics | 2000-12-13 |
| CAPTIA SYPHILIS-G ELISA TEST SYSTEM (K001525) | Trinity Biotech, Plc | 2000-11-29 |
| DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (K002262) | Diamedix Corp. | 2000-11-28 |
| C. DIFFICILE TOX A/B II (K003306) | Techlab, Inc. | 2000-11-22 |
| PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA (K002024) | Panbio, Inc. | 2000-11-22 |
| MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 (K002023) | Medmira Laboratories, Inc. | 2000-11-13 |
| PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI (K001177) | Enteric Products, Inc. | 2000-11-13 |
| ETEST LINEZOLID (K002139) | Ab Biodisk | 2000-11-08 |
| BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (K003204) | Intracel Corp. | 2000-11-07 |
| HARDYDISK CLINDAMYCIN, 2MCG (K002662) | Hardy Diagnostics | 2000-11-02 |
| HARDYDISK GENTAMICIN, 120MCG (K002369) | Hardy Diagnostics | 2000-10-26 |
| HARDYDISK LEVOFLOXACIN, 5MCG (K002664) | Hardy Diagnostics | 2000-10-26 |
| HARDY DISK CEFTIZOXIME, 30MCG (K002367) | Hardy Diagnostics | 2000-10-26 |
| HARDYDISK CEFOTETAN, 30MCG (K002661) | Hardy Diagnostics | 2000-10-26 |
| HARDYDISK LOMEFLOXACIN, 10MCG (K002660) | Hardy Diagnostics | 2000-10-26 |
| HARDYDISK CEFUROXIME, 30MCG (K002656) | Hardy Diagnostics | 2000-10-25 |
| HARDYDISK STREPTOMYCIN, 300MCG (K002368) | Hardy Diagnostics | 2000-10-25 |
| BACT/ALERT CSR (K003104) | Organon Teknika Corp. | 2000-10-20 |
| HARDYDISK NETILMICIN, 30MCG (K002663) | Hardy Diagnostics | 2000-10-19 |
| TREPCHEK TREPONEMAL ANTIBODY EIA (K001552) | Phoenix Biotech Corp. | 2000-10-19 |
| VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 (K001460) | bioMerieux, Inc. | 2000-10-04 |
| MODIFICATION TO: PRONTO DRY (K002451) | Medical Instruments Corporation, AG | 2000-09-29 |