| ANA SCREEN ELISA TEST SYSTEM (K940362) | Zeus Scientific, Inc. | 1994-07-28 |
| THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY (K936010) | Biomerica, Inc. | 1994-07-18 |
| HEMAGEN ACL IGA CALIBRATOR (K941840) | Hemagen Diagnostics, Inc. | 1994-06-30 |
| RADIAS ANA SCREEN ENZYME IMMUNOASSAY (K941509) | Bio-Rad | 1994-06-30 |
| AXSYM FERRITIN (K935847) | Abbott Laboratories | 1994-06-21 |
| DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI (K924726) | Dako Corp. | 1994-06-13 |
| DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45) (K932136) | Dako Corp. | 1994-06-13 |
| AUTOZYME SCREEN (K940700) | Cambridge Life Sciences Plc. | 1994-06-10 |
| ENA SCREEN ELISA TEST SYSTEM (K941014) | Zeus Scientific, Inc. | 1994-06-10 |
| ENA PROFILE-6 ELISA TEST SYSTEM (K941409) | Zeus Scientific, Inc. | 1994-06-10 |
| SELISA ANTI-N DNA ANTIBODIES (K940585) | Cambridge Life Sciences Plc. | 1994-06-10 |
| ENA EIA TEST KIT (K935413) | David A. Fuccillo, Ph.D. | 1994-06-02 |
| IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER (K940422) | The Binding Site, Ltd. | 1994-05-27 |
| HY-TEC TOTAL IGE ENZYME IMMUNOASSAY (K940183) | Hycor Biomedical, Inc. | 1994-05-17 |
| ELIAS ENA SCREEN (MICROTITER PLATE) (K940622) | Elias U.S.A., Inc. | 1994-05-11 |
| SYN ENA SCREEN (PIN PLATE) (K940229) | Elias U.S.A., Inc. | 1994-05-11 |
| MICROSOMAL EIA TEST KIT (K941361) | Immunoprobe, Inc. | 1994-05-11 |
| THYROGLOBULIN EIA TEST KIT (K941358) | Immunoprobe, Inc. | 1994-05-11 |
| JO-1 EIA TEST KIT (K935417) | David A. Fuccillo, Ph.D. | 1994-05-05 |
| LA EIA TEST KIT (K935419) | David A. Fuccillo, Ph.D. | 1994-05-05 |
| SCL-70 EIA TEST KIT (K935418) | David A. Fuccillo, Ph.D. | 1994-05-05 |
| MITOCHONDRIA EIA TEST KIT (K940251) | David A. Fuccillo, Ph.D. | 1994-05-03 |
| HISTONE EIA TEST KIT (K940253) | David A. Fuccillo, Ph.D. | 1994-05-02 |
| RNP EIA TEST KIT (K935415) | David A. Fuccillo, Ph.D. | 1994-05-02 |
| RO EIA TEST KIT (K935416) | David A. Fuccillo, Ph.D. | 1994-05-02 |
| SM EIA TEST KIT (K935414) | David A. Fuccillo, Ph.D. | 1994-05-02 |
| OT IGG SORBENT (K934324) | Organon Teknika Corp. | 1994-04-21 |
| BECKMAN BETA-2-MICROGLOBULIN (B2M) (K940353) | Beckman Instruments, Inc. | 1994-04-21 |
| MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM (K934594) | Ciba Corning Diagnostics Corp. | 1994-04-21 |
| ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT (K940510) | Helix Diagnostics, Inc. | 1994-04-20 |
| HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) (K935828) | Hemagen Diagnostics, Inc. | 1994-04-20 |
| ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT (K940588) | Helix Diagnostics, Inc. | 1994-04-20 |
| VENTANA NEGATIVE CONTROL REAGENT (K931979) | Ventana Medical Systems, Inc. | 1994-03-30 |
| ELIAS ANA TOTAL (K940641) | Elias U.S.A., Inc. | 1994-03-25 |
| SYNELISA ANA TOTAL (K935468) | Elias U.S.A., Inc. | 1994-03-25 |
| N-ASSAY TIA IGA (K933971) | Crestat Diagnostics, Inc. | 1994-03-22 |
| ALATOP(R) MICROPLATE ALLERGY SCREEN (K935488) | Diagnostic Products Corp. | 1994-03-22 |
| N-ASSAY TIA IGG (K933972) | Crestat Diagnostics, Inc. | 1994-03-22 |
| N-ASSAY TIA IGM (K933970) | Crestat Diagnostics, Inc. | 1994-03-22 |
| ACCESS SPECIFIC IGE ASSAY (K935876) | Bio-Rad Laboratories, Inc. | 1994-03-11 |
| MAST CLA ALLERGY SYSTEM (K934524) | Mast Immunosystems | 1994-03-07 |
| MAST CLA ALLERGY SYSTEM (K926420) | Mast Immunosystems | 1994-03-07 |
| RELISA ENA ANTIBODY SCREENING TEST SYSTEM (K935129) | Immuno Concepts, Inc. | 1994-01-31 |
| EL-RF TEST SYSTEM: EL-RF-IGM KIT (K933712) | Theratest Laboratories, Inc. | 1994-01-28 |
| DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH (K935528) | E.I. Dupont DE Nemours & Co., Inc. | 1994-01-28 |
| N-ASSAY TIA MULTI V-NL (K933973) | Crestat Diagnostics, Inc. | 1994-01-28 |
| SYNELISA CARDIOLIPIN ANTIBODIES (K935288) | Elias U.S.A., Inc. | 1994-01-24 |
| ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS (K930796) | Alko Diagnostic Corp. | 1994-01-13 |
| SPQ PAL CONTROL LEVEL II (K934966) | Incstar Corp. | 1994-01-11 |
| BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT (K933078) | Beckman Instruments, Inc. | 1994-01-11 |
| SPQ CRP CONTROL LEVEL II (K935075) | Incstar Corp. | 1994-01-11 |
| IMMUNOCARD MONO (K930778) | Meridian Diagnostics, Inc. | 1993-12-27 |
| QUANTA LITE(TM) HISTONE ELISA (K934053) | Inova Diagnostics, Inc. | 1993-12-21 |
| AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM (K933267) | Zeus Scientific, Inc. | 1993-12-15 |
| ELIAS CARDIOLIPIN IGM ANTIBODIES (K933392) | Elias U.S.A., Inc. | 1993-12-08 |
| ELIAS CARDIOLIPIN IGG ANTIBODIES (K933393) | Elias U.S.A., Inc. | 1993-12-08 |
| SYNELISA ANA PROFILE (K932206) | Elias U.S.A., Inc. | 1993-12-03 |
| LACTOFERRIN MICROASSAY SYSTEM (K934473) | Touch Scientific, Inc. | 1993-12-03 |
| DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT (K932876) | Shield Diagnostics, Ltd. | 1993-11-15 |
| BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY (K933589) | Boehringer Mannheim Corp. | 1993-11-03 |
| DIASTAT ANTI-CENTROMERE KIT (K932877) | Shield Diagnostics, Ltd. | 1993-10-15 |
| BECKMAN TRANSFERRIN KIT (K926272) | Beckman Instruments, Inc. | 1993-10-07 |
| IMMULITE BETA-2-MICROGLOBULIN (K931702) | Diagnostic Products Corp. | 1993-09-24 |
| ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK (K933648) | Dupont Medical Products | 1993-09-24 |
| ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN (K932850) | Helix Diagnostics, Inc. | 1993-09-24 |
| SYNELISA CENP-B ANTIBODIES (K931255) | Elias U.S.A., Inc. | 1993-09-24 |
| ENCORE ENA COMBINED EIA (K931543) | Clark Laboratories, Inc. | 1993-09-08 |
| RADIAS FERRITIN ENZYME IMMUNOASSAY (K933314) | Bio-Rad | 1993-09-08 |
| EYE SPOT IM TEST (K932688) | J.S. Medical Assoc. | 1993-09-08 |
| EYE SPOT CRP TEST (K932180) | J.S. Medical Assoc. | 1993-08-23 |
| SYNELISA TG ANTIBODIES/TPO ANTIBODIES (K933123) | Elias U.S.A., Inc. | 1993-08-23 |
| EYE SPOT RF TEST (K932437) | J & S Medical Assoc., Inc. | 1993-08-23 |
| RHEUMELISA II HISTONE ANTIBODY TEST KIT (K932679) | Biowhittaker Molecular Applications, Inc. | 1993-08-23 |
| SYLNELISA HISTONE ANTIBODIES (K932302) | Elias U.S.A., Inc. | 1993-08-23 |
| IMMULITE TOTAL IGE (K931703) | Diagnostic Products Corp. | 1993-08-16 |
| ANA PROFILE I (K932424) | Apotex Scientific, Inc. | 1993-08-10 |
| CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) (K930987) | The Binding Site, Ltd. | 1993-08-10 |
| ACCUTEX IM LATEX TEST (K932551) | J.S. Medical Assoc. | 1993-08-09 |
| VENTANA RED DETECTION KIT (K932386) | Ventana Medical Systems, Inc. | 1993-08-09 |
| PSA ANTIBODY KIT (K932326) | Ventana Medical Systems, Inc. | 1993-08-06 |
| ANTI-SS-B/LA ANTIBODY TEST (K932419) | Helix Diagnostics, Inc. | 1993-08-05 |
| COBAS(R) CORE IGE TOTAL EIA (K930890) | Roche Diagnostic Systems, Inc. | 1993-08-05 |
| QUANTA LITE MITOCHONDRIA M2 ELISA (K933180) | Inova Diagnostics, Inc. | 1993-08-05 |
| VISTA FERRITIN ASSAY (K931576) | Syva Co. | 1993-08-05 |
| SYNELISA PARIETAL CELL ANTIBODIES (K930422) | Elias U.S.A., Inc. | 1993-08-03 |
| IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE (K931806) | The Binding Site, Ltd. | 1993-07-16 |
| ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT (K931495) | Helix Diagnostics, Inc. | 1993-07-16 |
| HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 (K932373) | Hemagen Diagnostics, Inc. | 1993-07-16 |
| LACTOCARD (K931901) | Touch Scientific, Inc. | 1993-07-06 |
| ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM (K932225) | Immuno Concepts, Inc. | 1993-07-06 |
| SYNELISA RO ABS / LA ABS (K930209) | Elias U.S.A., Inc. | 1993-06-11 |
| ACCESS(R) TOTAL IGE ASSAY (K930984) | Bio-Rad Laboratories, Inc. | 1993-06-09 |
| ANTI-ENDOMYSIAL ANTIBODY TEST (K912551) | Immco Diagnostics, Inc. | 1993-06-09 |
| VIDAS TOTAL IGE (IGE) ASSAY (K931224) | Biomerieux Vitek, Inc. | 1993-05-20 |
| HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM (K926114) | Tissue Culture Biotec, Inc. | 1993-05-20 |
| ELISA-DOXA COMBI-6 (K924952) | Advanced Biological Products, Inc. | 1993-05-19 |
| ELISA-DOXA SSB (K924946) | Advanced Biological Products, Inc. | 1993-05-19 |
| ELISA-DOXA SM/RNP (K924948) | Advanced Biological Products, Inc. | 1993-05-19 |
| ELISA-DOXA COMBI-4 (K924951) | Advanced Biological Products, Inc. | 1993-05-19 |
| ELISA-DOXA SM (K924947) | Advanced Biological Products, Inc. | 1993-05-19 |