| CHEMMATE LAMBDA (K973392) | Ventana Medical Systems, Inc. | 1997-10-03 |
| CHEMMATE KAPPA (K973391) | Ventana Medical Systems, Inc. | 1997-10-03 |
| CHEMMATE L26 (CD20) (K973390) | Ventana Medical Systems, Inc. | 1997-10-03 |
| IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE (K973186) | Diagnostic Products Corp. | 1997-09-29 |
| RETINOL BINDING PROTEIN RBP RID KIT (K973189) | The Binding Site, Ltd. | 1997-09-29 |
| CHEMMATE LCA (K973393) | Ventana Medical Systems, Inc. | 1997-09-25 |
| AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K972462) | Bayer Corp. | 1997-09-22 |
| IMMULITE CEA (K970877) | Diagnostic Products Corp. | 1997-09-22 |
| PROSTATE SPECIFIC ANTIGEN METHOD (K973101) | Dade Chemistry Systems, Inc. | 1997-09-18 |
| AXSYM CA 15-3 (K963926) | Abbott Laboratories | 1997-09-15 |
| MODIFICATION OF OPUS FERRITIN TEST SYSTEM (K973202) | Behring Diagnostics, Inc. | 1997-09-12 |
| RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT (K972220) | Randox Laboratories, Ltd. | 1997-09-09 |
| UNICAP PHADIATOP (K972364) | Pharmacia, Inc. | 1997-09-04 |
| RAICHEM PREALBUMIN SPIA (K972812) | Hemagen Diagnostics, Inc. | 1997-08-28 |
| OSOM MONO TEST 143 (K972231) | Wyntek Diagnostics, Inc. | 1997-08-26 |
| IMMULITE 2000 PSA (K972095) | Diagnostic Products Corp. | 1997-08-22 |
| SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT (K971958) | Beckman Instruments, Inc. | 1997-08-20 |
| ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) (K970695) | Chiron Diagnostics Corp. | 1997-08-08 |
| N-ASSAY TIA APO A1/B MULTI CALIBRATOR (K964294) | Crestat Diagnostics, Inc. | 1997-08-01 |
| N-ASSAY TIA APO B TEST KIT (K964296) | Crestat Diagnostics, Inc. | 1997-08-01 |
| CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST (K972160) | Trinity Laboratories, Inc. | 1997-08-01 |
| N-ASSAY TIA APO A1 TEST KIT (K964292) | Crestat Diagnostics, Inc. | 1997-08-01 |
| TINA-QUANT FERRITIN ASSAY (K964282) | Boehringer Mannheim Corp. | 1997-07-30 |
| TINAQUANT MYOGLOBIN ASSAY (K972513) | Boehringer Mannheim Corp. | 1997-07-28 |
| ELECSYS PSA ASSAY (K964351) | Boehringer Mannheim Corp. | 1997-07-25 |
| ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM (K971784) | Zeus Scientific, Inc. | 1997-07-23 |
| CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER (K971418) | Chiron Diagnostics Corp. | 1997-07-17 |
| N-ASSAY TIA MULTI V-NL (K964299) | Crestat Diagnostics, Inc. | 1997-07-14 |
| N-ASSAY TIA MULTI V-NL (K964301) | Crestat Diagnostics, Inc. | 1997-07-14 |
| N-ASSAY TIA MULTI V-NL (K964298) | Crestat Diagnostics, Inc. | 1997-07-14 |
| N-ASSAY TIA C4 TEST KIT (K964297) | Crestat Diagnostics, Inc. | 1997-07-14 |
| N-ASSAY TIA MULTI V-NL (K964300) | Crestat Diagnostics, Inc. | 1997-07-14 |
| THYROGLOBULIN ASSAY SYSTEM (K972190) | American Laboratory Products Co., Ltd. | 1997-07-14 |
| N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT (K965100) | Crestat Diagnostics, Inc. | 1997-07-14 |
| N-ASSAY TIA C1-INACTIVATOR TEST KIT (K965024) | Crestat Diagnostics, Inc. | 1997-07-14 |
| UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 (K972068) | Pharmacia, Inc. | 1997-07-03 |
| N-ASSAY TIA MULTI CRP CALIBRATOR SET (K965110) | Crestat Diagnostics, Inc. | 1997-07-03 |
| ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (K971834) | Monobind | 1997-07-03 |
| ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA (K971835) | Monobind | 1997-07-03 |
| ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT (K971602) | Beckman Instruments, Inc. | 1997-06-27 |
| SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY (K970612) | Sealite Sciences, Inc. | 1997-06-24 |
| OPUS PSA TEST SYSTEM (K964595) | Behring Diagnostics, Inc. | 1997-06-24 |
| QUANTA LITE B2GPI IGG (K970551) | Inova Diagnostics, Inc. | 1997-06-24 |
| QUANTA LITE RF IGM (K971614) | Inova Diagnostics, Inc. | 1997-06-20 |
| VIRGO AMA ELISA KIT (K971909) | Hemagen Diagnostics, Inc. | 1997-06-20 |
| TINAQUANT RHEUMATOID FACTOR ASSAY (K971379) | Boehringer Mannheim Corp. | 1997-06-17 |
| N-ASSAY TIA TRANSFERRIN TEST KIT (K964295) | Crestat Diagnostics, Inc. | 1997-06-16 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT (K964842) | Beckman Instruments, Inc. | 1997-06-11 |
| ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA (K970177) | Immco Diagnostics, Inc. | 1997-06-11 |
| SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR (K971788) | Beckman Instruments, Inc. | 1997-06-03 |
| HEMAGEN ANTI CARDIOLIPIN SCREEN (K971039) | Hemagen Diagnostics, Inc. | 1997-06-03 |
| ELECSYS FERRITIN (K971833) | Boehringer Mannheim Corp. | 1997-06-02 |
| QUANTA LITE IGA GLIADIN ELISA (K964986) | Inova Diagnostics, Inc. | 1997-06-02 |
| QUANTA LITE IGG GLIADIN ELISA (K964985) | Inova Diagnostics, Inc. | 1997-05-30 |
| IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT (K964341) | Immco Diagnostics, Inc. | 1997-05-30 |
| IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT (K964344) | Immco Diagnostics, Inc. | 1997-05-30 |
| QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( (K964767) | R&D Systems, Inc. | 1997-05-29 |
| B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964791) | Bayer Corp. | 1997-05-29 |
| QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (K970718) | R&D Systems, Inc. | 1997-05-27 |
| MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT (K971658) | Jay H. Geller | 1997-05-23 |
| CENTOCOR CA 15-3 RIA MODEL NO. 800-033 (K963803) | Centocor, Inc. | 1997-05-23 |
| HYCOR ALLERGEN DISC (K965094) | Hycor Biomedical, Inc. | 1997-05-21 |
| ANCA COMBI DIAGNOSTIC TEST KIT (K965133) | The Binding Site, Ltd. | 1997-05-21 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT (K964781) | Beckman Instruments, Inc. | 1997-05-09 |
| AURA TEK FDP (K970353) | Perimmune, Inc. | 1997-04-30 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT (K964695) | Beckman Instruments, Inc. | 1997-04-29 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT (K964762) | Beckman Instruments, Inc. | 1997-04-25 |
| VENTANA ANTI-S100 PRIMARY ANTIBODY (K941514) | Ventana Medical Systems, Inc. | 1997-04-25 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) (K964766) | Beckman Instruments, Inc. | 1997-04-25 |
| UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (K964152) | Pharmacia, Inc. | 1997-04-23 |
| VENTANA ANTI-MELANOMA PRIMARY ANTIBODY (K941170) | Ventana Medical Systems, Inc. | 1997-04-22 |
| ANTI-MUSCLE ACTIN PRIMARY ANTIBODY (K941707) | Ventana Medical Systems, Inc. | 1997-04-21 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT (K965033) | Beckman Instruments, Inc. | 1997-04-21 |
| RAICHEM RHEUMATOID FACTOR SPIA (K970373) | Henage Diagnostics, Inc. | 1997-04-17 |
| BARD AND BTA TEST (K964151) | Bard Diagnostic Sciences,Inc. | 1997-04-16 |
| MYELOPEROXIDASE ELISA TEST SYSTEM (K964446) | Zeus Scientific, Inc. | 1997-04-10 |
| ANCA SCREEN ELISA TEST SYSTEM (K964449) | Zeus Scientific, Inc. | 1997-04-10 |
| PROTEINASE-3 IGG ELISA TEST SYSTEM (K964448) | Zeus Scientific, Inc. | 1997-04-10 |
| IS-ANTI-JO-1 TEST SYSTEM (K970228) | Diamedix Corp. | 1997-04-08 |
| IS-ANTI-SM TEST SYSTEM (K970220) | Diamedix Corp. | 1997-04-08 |
| IS-ANTI-SSA TEST SYSTEM (K970218) | Diamedix Corp. | 1997-04-08 |
| IS-ANTI-SM/RNP (720-270) (K970238) | Diamedix Corp. | 1997-04-08 |
| MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM (K964787) | Mardx Diagnostics, Inc. | 1997-04-08 |
| IS-ANTI-SSB TEST SYSTEM (720-260) (K970237) | Diamedix Corp. | 1997-04-08 |
| IS-ANTI-SCL-70 TEST SYSTEM (720-280) (K970239) | Diamedix Corp. | 1997-04-08 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT (K964257) | Beckman Instruments, Inc. | 1997-03-24 |
| IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT (K963976) | Beckman Instruments, Inc. | 1997-03-19 |
| ENZYMUN-TEST PSA (K965085) | Boehringer Mannheim Corp. | 1997-03-19 |
| HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY (K962730) | Hycor Biomedical, Inc. | 1997-03-07 |
| HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY (K962578) | Hycor Biomedical, Inc. | 1997-03-07 |
| HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY (K962727) | Hycor Biomedical, Inc. | 1997-03-07 |
| HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY (K962720) | Hycor Biomedical, Inc. | 1997-03-07 |
| HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY (K962731) | Hycor Biomedical, Inc. | 1997-03-07 |
| HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY (K962719) | Hycor Biomedical, Inc. | 1997-03-07 |
| HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY (K962729) | Hycor Biomedical, Inc. | 1997-03-07 |
| HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY (K962722) | Hycor Biomedical, Inc. | 1997-03-07 |
| HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY (K962728) | Hycor Biomedical, Inc. | 1997-03-07 |
| SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (K965108) | Beckman Instruments, Inc. | 1997-03-06 |
| ELIAS ANA-HEP-2 (K964385) | Elias U.S.A., Inc. | 1997-03-06 |
| IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (K963974) | Beckman Instruments, Inc. | 1997-03-06 |