| SAS SERUM/URINE HCG (K965250) | Sascie | 1997-02-18 |
| ONE-STEP DIPSTICK PREGNANCY TEST (K964536) | Teco Diagnostics | 1997-02-11 |
| ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST (K964462) | Teco Diagnostics | 1997-02-11 |
| ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST (K964461) | Teco Diagnostics | 1997-02-11 |
| OSOM CLASSIC HCG-URINE TEST (115) (K965227) | Wyntek Diagnostics, Inc. | 1997-02-04 |
| AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST (K964574) | Athena Medical Corp. | 1997-01-21 |
| SAS ONE-STEP PREGNANCY (K964995) | Sa Scientific, Inc. | 1997-01-21 |
| EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST (K963231) | Excel Scientific, Inc. | 1996-12-04 |
| CONTRAST STRIP HCG (K964156) | Genzyme Diagnostics | 1996-11-25 |
| CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST (K964155) | Genzyme Diagnostics | 1996-11-25 |
| MINI STRIP/SERUM HCG (K963132) | International Newtech Development, Inc. | 1996-11-18 |
| PS-UNIT CASSETTE/SERUM HCG (K963133) | International Newtech Development, Inc. | 1996-11-18 |
| VISUALINE D HCG (K963408) | Sun Biomedical Laboratories, Inc. | 1996-10-18 |
| SCRIPPS LABORATORIES HCG ONE-STEP (K962906) | Scripps Laboratories, Inc. | 1996-08-23 |
| BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT (K954065) | Biochem Immunosystems (U.S.), Inc. | 1996-07-10 |
| DSL ACTIVE I-HCG ELISA (K961911) | Diagnostic Systems Laboratories, Inc. | 1996-06-28 |
| DSL ACTIVE I-HCG IRMA (K960357) | Diagnostic Systems Laboratories, Inc. | 1996-05-07 |
| BIONIKE A/Q PREGNANCY TEST (K960992) | Bionike Laboratories, Inc. | 1996-04-25 |
| ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT (K955353) | Tcpi, Inc. | 1996-03-19 |
| ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT (K955266) | Boehringer Mannheim Italia Spa | 1996-02-29 |
| MIT ONE STEP PREGNANCY TEST (K953486) | 3c Diagnostics, Inc. | 1995-12-21 |
| QUIX RAPID PREGNANCY STRIP TEST (K954993) | Guardian Scientific, Corp. | 1995-12-13 |
| BIONIKE A/Q PREGNANCY TEST (K954901) | Bionike Laboratories, Inc. | 1995-12-11 |
| ACCESS TOTAL BHCG ASSAY (MODIFICATION) (K954732) | Bio-Rad Laboratories, Inc. | 1995-11-20 |
| CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG (K954273) | Quidel Corp. | 1995-10-16 |
| TESTPACK PLUS HCG URINE (K954029) | Abbott Laboratories | 1995-10-05 |
| MINISTRIP HCG (K951705) | International Newtech Development, Inc. | 1995-10-03 |
| WYNTEK OSOM HCG-URINE TEST (K953383) | Wyntek Diagnostics, Inc. | 1995-08-29 |
| CONTRAST & RAPID HCG URINE/SERUM TST (K952319) | Medix Biotech, Inc. | 1995-06-20 |
| BIONIKE A/Q PREGNANCY TEST (K951136) | Charlton Assoc. | 1995-04-20 |
| QUICK CHECKER HCG PREGNANCY TEST (K943859) | Mizuho USA, Inc. | 1995-02-10 |
| QUIKPAC II, ONE STEP HCG COMBO KIT (K945951) | Syntron Bioresearch, Inc. | 1995-02-08 |
| RAPIDVUE(TM) HCG (K945969) | Quidel Corp. | 1995-01-27 |
| VISUALINE II HCG (K943239) | Sun Biomedical Laboratories, Inc. | 1994-12-07 |
| BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE (K944426) | Princeton BioMeditech Corp. | 1994-10-25 |
| UC QIK 1-STEP HCG TEST (K942464) | Eucardio Laboratory, Inc. | 1994-09-20 |
| AXSYM TOTAL B-HCG (K935673) | Abbott Laboratories | 1994-06-21 |
| ONE STEP PREGNANCY TEST (K936031) | Teco Diagnostics | 1994-04-15 |
| KODAK SURECELL HCG URINE TEST, MODIFICATION (K936287) | Eastman Kodak Company | 1994-04-08 |
| KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION (K936138) | Eastman Kodak Company | 1994-04-08 |
| EVENT TEST STRIP HCG (K935502) | Boehringer Mannheim Italia Spa | 1994-01-27 |
| KINGS BAY PRELUDE ONE STEP HCG COMBO KIT (K931698) | King'S Bay Intl., Inc. | 1993-11-05 |
| MEDIX BIOTECH BESTEST HCG-URINE TEST KIT (K932758) | Medix Biotech, Inc. | 1993-09-28 |
| OPUS(R) TOTAL B-HCG TEST SYSTEM (K932279) | Pb Diagnostic Systems, Inc. | 1993-07-08 |
| QUICKVUE ONE-STEP HCG COMBO (K932042) | Quidel Corp. | 1993-06-29 |
| PRO-STEP PT HCG (K925303) | Disease Detection International, Inc. | 1993-06-15 |
| SAS PREGNANCY STRIP (K931302) | Sa Scientific, Inc. | 1993-06-09 |
| UC QIK PREGNANCY TEST (K926500) | Eucardio Laboratory, Inc. | 1993-06-07 |
| CLEARVIEW HCG (K924673) | Unipath , Ltd. | 1993-05-11 |
| PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST (K930014) | Vanguard Biomedical Corp. | 1993-03-25 |
| CIBA CORNING ACS HCG IMMUNOASSAY (K925277) | Ciba Corning Diagnostics Corp. | 1993-03-19 |
| PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG (K926356) | Becton Dickinson Advanced Diagnostics | 1993-03-18 |
| VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY (K926342) | Syva Co. | 1993-02-17 |
| ACCESS TOTAL BHCG ASSAY (K926198) | Bio-Rad Laboratories, Inc. | 1993-02-08 |
| SAS ONE STEP PREGNANCY (K926204) | Sa Scientific, Inc. | 1993-02-02 |
| PRO-STEP HCG (K925125) | Disease Detection International, Inc. | 1993-01-13 |
| HCG STAT-PAK (K923925) | Chembio Diagnostic Systems, Inc. | 1992-12-24 |
| QUICKVUE ONE-STEP HCG TEST (K925435) | Quidel Corp. | 1992-12-03 |
| MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 (K924259) | Medix Biotech, Inc. | 1992-11-25 |
| VISUAL HCG PREGNANCY TEST (K923376) | Tech-Co, Inc. | 1992-10-01 |
| ANI BIOCARD HCG TEST (K923030) | Ani OY | 1992-09-15 |
| HCG PREGNANCY ONE STEP TEST STRIP (K923123) | Tcpi, Inc. | 1992-09-09 |
| DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD (K922697) | E.I. Dupont DE Nemours & Co., Inc. | 1992-08-10 |
| VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K921302) | Vitek Systems, Inc. | 1992-07-28 |
| SINGLE-STEP PREGNANCY, HCG TEST (K922290) | American Medical Products, Inc. | 1992-07-09 |
| MIRCO ELISA HPL TEST KIT (K921212) | Bio Clinic Co. | 1992-05-07 |
| NOW PREGNANCY TEST KIT (K921211) | Bio Clinic Co. | 1992-05-07 |
| TMB CHROMOGEN/SUBSTRATE REAGENT SET (K920918) | Bio Clinic Co. | 1992-04-07 |
| AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR (K920505) | Eastman Kodak Company | 1992-03-23 |
| MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT (K920253) | Medix Biotech, Inc. | 1992-02-14 |
| KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION (K915701) | Eastman Kodak Company | 1992-01-27 |
| PRECISE TM HCG (K915197) | Becton Dickinson Advanced Diagnostics | 1991-12-17 |
| PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA (K915200) | Becton Dickinson Advanced Diagnostics | 1991-12-16 |
| MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 (K914696) | Medix Biotech, Inc. | 1991-11-13 |
| CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF (K914240) | Unipath , Ltd. | 1991-10-25 |
| TARGET(TM)-HOG (K914303) | V-Tech, Inc. | 1991-10-11 |
| PROCLINIC ONE STEP PREGNANCY TEST (K914253) | Vanguard Biomedical Corp. | 1991-10-11 |
| DIRECTIGEN 1-2-3(TM) HCG TEST (K913122) | Quidel Corp. | 1991-08-16 |
| IMMUNOCARD HCG ONE STEP (I-S) TEST KIT (K911826) | Disease Detection International, Inc. | 1991-07-19 |
| IMX TOTAL B-HCG (K912535) | Abbott Laboratories | 1991-07-01 |
| IMX HCG (K912534) | Abbott Laboratories | 1991-07-01 |
| OBA(TM) SERUM HCG ASSAY (K911047) | Adeza Biomedical | 1991-06-24 |
| CLEARVIEW HCG SERUM/URINE (K905741) | Unipath , Ltd. | 1991-05-15 |
| IMMUNOCORP COATED TUBE IRMA HCG (K910349) | Immunocorp | 1991-03-21 |
| BIOCLONE'S ELEGANCE HCG ELISA KIT (K910420) | Bioclone Australia Pty , Ltd. | 1991-02-26 |
| TARGET(TM) HOG ONE STEP (K903937) | V-Tech, Inc. | 1990-10-22 |
| MAXI TEST (K904016) | Bhc Biotech , Ltd. | 1990-10-15 |
| CIBA CORNING ACS HCG IMMUNOASSAY (K904123) | Ciba Corning Diagnostics Corp. | 1990-10-03 |
| ABBOTT TESTPACK PLUS TM HCG-COMBO (K903219) | Abbott Laboratories | 1990-09-25 |
| AFFINITY HCG TEST SYSTEM (K902720) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-08-09 |
| EZ-SCREEN:HCG (K902681) | Environmental Diagnostics, Inc. | 1990-08-09 |
| KODAK SURECELL(TM) HCG-URINE TEST KIT (K902136) | Eastman Kodak Company | 1990-06-28 |
| OPUS (TM) HCG (K901935) | Pb Diagnostic Systems, Inc. | 1990-06-26 |
| BIOSIGN HCG-ONE STEP PREGNANCY TEST (K901011) | Princeton Biomedix | 1990-05-04 |
| LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC (K901484) | London Diagnostics, Inc. | 1990-05-01 |
| IMX HCG (LIST #03A63) (K900327) | Abbott Laboratories | 1990-04-18 |
| HCG SOLID PHASE COMPONENT SYSTEM (K901045) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-03-29 |
| MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT (K896587) | Medix Biotech, Inc. | 1990-02-16 |
| ENZYMUN TEST R HCG (K896901) | Boehringer Mannheim Corp. | 1990-02-08 |
| SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY (K894175) | Serono-Baker Diagnostics, Inc. | 1989-12-19 |