| STA-COAG CONTROL [P] PLUS KIT (K952338) | American Bioproducts Co. | 1995-09-21 |
| AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II (K952720) | Aalto Scientific, Ltd. | 1995-09-20 |
| DATACELL 18MS (K945678) | Danam Electronics | 1995-09-12 |
| OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL (K953498) | Immunotech, Inc. | 1995-09-08 |
| ADP REAGENT, MODIFIED (K952252) | Helena Laboratories | 1995-09-08 |
| SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER (K952560) | Sienco, Inc. | 1995-09-05 |
| CASCASE 480 SNSLYZER (K951497) | Helena Laboratories | 1995-09-01 |
| SF-CHECK (K952245) | Streck Laboratories, Inc. | 1995-09-01 |
| ROTACHROM HEPARIN TEST KIT (K943515) | American Bioproducts Co. | 1995-08-31 |
| ROTACHROM HBPM/LMWH TEST KIT (K943516) | American Bioproducts Co. | 1995-08-31 |
| CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT (K950742) | Coulter Corp. | 1995-08-25 |
| FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 (K946265) | Clinical Controls, Inc. | 1995-08-24 |
| FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 (K946193) | More Diagnostics | 1995-08-24 |
| TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP (K950057) | Becton Dickinson Immunocytometry Systems | 1995-08-22 |
| OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES (K952789) | Immunotech Corp. | 1995-08-14 |
| COATEST(R) APC(TM) RESISTANCE (K945940) | Axis-Shield Doc AS | 1995-08-07 |
| ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS (K951071) | Alko Diagnostic Corp. | 1995-07-24 |
| COULTER MH025A (K950949) | Coulter Corp. | 1995-07-20 |
| BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES (K942087) | Biopool AB | 1995-07-13 |
| COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN (K946274) | Helena Laboratories | 1995-07-11 |
| OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES (K952182) | Immunotech, Inc. | 1995-07-05 |
| GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A (K933934) | Sigma Diagnostics, Inc. | 1995-06-29 |
| CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES (K944126) | Caltag Laboratories, Inc. | 1995-06-20 |
| CALTAG CD4 R-PE MONOCLONAL ANTIBODY (K944128) | Caltag Laboratories, Inc. | 1995-06-20 |
| CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY (K944127) | Caltag Laboratories, Inc. | 1995-06-20 |
| MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS (K943571) | More Diagnostics | 1995-06-15 |
| SYSMEX(TM) F-820, 520 (K945837) | Sysmex Corp. | 1995-06-09 |
| ABBOTT VISION GLYCATED HB, MODIFICATION (K936285) | Abbott Laboratories | 1995-06-09 |
| THE STACHROM HEPARIN ASSAY KIT (K925433) | American Bioproducts Co. | 1995-05-23 |
| HEMOLAB COFAC IX (K942050) | Biomerieux Vitek, Inc. | 1995-05-19 |
| BIOMERIEUX HEMOLAB COFAC II (K942049) | Biomerieux Vitek, Inc. | 1995-05-19 |
| TRAX(TM) CD4 TEST KIT (K925255) | T Cell Diagnostics, Inc. | 1995-05-15 |
| STACLOT HEPARIN TEST KIT (K943517) | American Bioproducts Co. | 1995-05-11 |
| ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL (K940209) | Ortho Diagnostic Systems, Inc. | 1995-05-11 |
| COAGUCHEK SYSTEM (K942884) | Boehringer Mannheim Corp. | 1995-05-11 |
| HEPARIN MANAGEMENT TEST CARD; HMT CARD (K943283) | Cardiovascular Diagnostics, Inc. | 1995-05-10 |
| H292 (K942820) | Bartels, Inc. | 1995-05-05 |
| OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES (K950626) | Immunotech Corp. | 1995-05-05 |
| DCA 2000 SYSTEM FOR HEMOGLOBIN A1C (K951361) | Heraeus Kulzer, Inc. | 1995-05-05 |
| PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (K935598) | Clinical Controls, Inc. | 1995-05-02 |
| HEMOCHRON HNPT/FACTOR VI PT+ (K945078) | International Technidyne Corp. | 1995-04-28 |
| ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT (K935748) | Ortho Diagnostic Systems, Inc. | 1995-04-26 |
| ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE) (K932532) | Ortho Diagnostic Systems, Inc. | 1995-04-26 |
| ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE (K932531) | Ortho Diagnostic Systems, Inc. | 1995-04-26 |
| ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE) (K932530) | Ortho Diagnostic Systems, Inc. | 1995-04-26 |
| ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE) (K941713) | Ortho Diagnostic Systems, Inc. | 1995-04-26 |
| EZ-RANGE (K941965) | Hematronix, Inc. | 1995-04-25 |
| BEHRING FIBRINTIMER A (K926551) | Behring Diagnostics, Inc. | 1995-04-18 |
| N/T PROTEIN CONTROL PY (K951012) | Behring Diagnostics, Inc. | 1995-04-17 |
| VARIANT TOTAL GHB PROGRAM (K941616) | Bio-Rad | 1995-04-14 |
| AT-III CALIBRATOR (K944279) | American Bioproducts Co. | 1995-04-07 |
| HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES (K936056) | Dipro Diagnostic Products GmbH | 1995-04-05 |
| DV TEST AND DVV CONFIRM (K940490) | American Diagnostica, Inc. | 1995-04-05 |
| MICROSAMPLE COAGULATION ANALYZER (K943153) | Bio/Data Corp. | 1995-03-24 |
| TOA MEDICAL ELECTRONICS CA-1000 (K942096) | Sysmex Corp. | 1995-03-24 |
| TOA MEDICAL ELECTRONICS CA-5000 (K942097) | Sysmex Corp. | 1995-03-24 |
| HEPARIN ASSAY CARTRIDGES AND CONTROLS (K944115) | Medtronic Hemotec, Inc. | 1995-03-24 |
| STA SYSTEM CONTROL [N] + [P] KIT (K943518) | American Bioproducts Co. | 1995-03-21 |
| PTT-LT TEST KIT (K941210) | American Bioproducts Co. | 1995-03-21 |
| ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II (K944691) | International Technidyne Corp. | 1995-03-15 |
| CRIT-LINE HEMATOCRIT ALERT (K950942) | In-Line Diagnostics Corp. | 1995-03-14 |
| HUMAN PROTEIN C RID TEST KIT (K950015) | Jay H. Geller | 1995-03-06 |
| ONYX (K943967) | Coulter Corp. | 1995-03-06 |
| IKAROS (K940240) | Metasystems GmbH | 1995-02-24 |
| THROMBOSCREEN THROMBOPLASTIN-DS (K940082) | Pacific Hemostasis | 1995-02-14 |
| SEDRATROL (K940430) | Medical Specialties Intl., Inc. | 1995-02-06 |
| ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER (K944227) | Medical Laboratory Automation Systems, Inc. | 1995-02-03 |
| SYSMEX K-4500 (K943894) | Sysmex Corp. | 1995-02-03 |
| STA AUTOMATED MULTI-PARAMETRIC ANALYZER (K942117) | American Bioproducts Co. | 1995-02-01 |
| MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910) (K945692) | Dako Corp. | 1995-01-25 |
| PROTEIN C REAGENT, COAGULOMETRIC (K924425) | Behring Diagnostics, Inc. | 1995-01-24 |
| QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (K942222) | Isolab, Inc. | 1995-01-20 |
| QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (K942276) | Isolab, Inc. | 1995-01-20 |
| BIOMERIEUX HEMOLAB COFAC VII (K935850) | Biomerieux Vitek, Inc. | 1995-01-17 |
| BIOMERIEUX HEMOLAB COFAC X (K935851) | Biomerieux Vitek, Inc. | 1995-01-17 |
| RISTOCETIN COFACTOR ASSAY KIT (K945414) | Chrono-Log Corp. | 1995-01-11 |
| HEMOLAB (K931992) | Biomerieux Vitek, Inc. | 1994-12-22 |
| BIOMERIEUX HEMOLAB AT III (K934156) | Biomerieux Vitek, Inc. | 1994-12-22 |
| HEMOLAB PROTEIN C CHROMOGENIC ASSAY (K934210) | Biomerieux Vitek, Inc. | 1994-12-22 |
| SCS-1000 (SYSMEX CALIBRATOR SYSTEM) (K943268) | Streck Laboratories, Inc. | 1994-12-15 |
| TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K941171) | Miles, Inc. | 1994-12-14 |
| RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE (K943335) | R&D Systems, Inc. | 1994-12-12 |
| RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE (K943336) | R&D Systems, Inc. | 1994-12-12 |
| COULTER FLOW SET (K944751) | Coulter Corp. | 1994-12-08 |
| APTT-ES (K935169) | Helena Laboratories | 1994-12-02 |
| HUMAN NEWBORN FORESKIN CELL CULTURE (K943887) | Neogenex | 1994-11-28 |
| RD CULTURE CELL (K943891) | Neogenex | 1994-11-28 |
| PRIMARY RABBIT KIDNEY CELL CULTURE (K943885) | Neogenex | 1994-11-28 |
| VERO CELL CULTURE (K943889) | Neogenex | 1994-11-28 |
| PRIMARY MONKEY KIDNEY CELL CULTURE (K943884) | Neogenex | 1994-11-28 |
| WI38 CELL CULTURE (K943890) | Neogenex | 1994-11-28 |
| MDCK CELL CULTURE (K943888) | Neogenex | 1994-11-28 |
| BGM CELL CULTURE (K943886) | Neogenex | 1994-11-28 |
| DADE INNOVIN II (K935702) | Baxter Diagnostics, Inc. | 1994-11-22 |
| DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA (K935307) | Baxter Diagnostics, Inc. | 1994-11-22 |
| SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 (K941872) | Helena Laboratories | 1994-11-21 |
| MONOCLONAL MOUSE ANTI-HUMAN B-CELL (K943284) | Dako Corp. | 1994-11-21 |
| MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 (K944253) | Dako Corp. | 1994-11-21 |
| MONOCLONAL MOUSE ANTI-HUMAN T-CELL (K942797) | Dako Corp. | 1994-11-10 |
| AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 (K933086) | Helena Laboratories | 1994-10-31 |