| PREGNACOL PREGNANCY TEST (K972606) | Immunostics Inc., | 1997-08-29 |
| IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST (K921968) | Tech-Co, Inc. | 1996-06-28 |
| SAS(TM) DIRECT MONOCLONAL HCG (K935863) | Sa Scientific, Inc. | 1994-02-24 |
| ACCUTEX BETA-HCG TEST (K926112) | J.S. Medical Assoc. | 1993-07-28 |
| SAS(TM) MONOCLONAL HCG-SLIDE (K930609) | Sa Scientific, Inc. | 1993-03-29 |
| DIRECT PREGNANCY TEST (K920716) | Tech-Co, Inc. | 1992-03-24 |
| CLEARVIEW HCG (K910946) | Unipath , Ltd. | 1991-04-01 |
| PREGNOSPIA II (K881435) | Organon Teknika Corp. | 1988-05-27 |
| PREGNANCY (HCG) CARD & LIQUID TEST (K880163) | Ampcor, Inc. | 1988-05-17 |
| PREGNANCY BETA-HCG CARD & LIQUID TEST (K880478) | Ampcor, Inc. | 1988-04-28 |
| HCG-NOSTICK (K880328) | Organon Teknika Corp. | 1988-03-15 |
| V-TREND BETA-HCG DRY-SPOT TEST (K875262) | Texas Immunology, Inc. | 1988-02-02 |
| V-TREND BETA-HCG TEST (K874638) | Texas Immunology, Inc. | 1988-01-21 |
| ACU-PREG-AL SLIDE TEST (K871294) | Papibris Scientific, Inc. | 1987-05-12 |
| IMMUNO-CEPT D (BETA-MONOCLONAL) (K863741) | Immunostics Co., Inc. | 1986-11-13 |
| MONO ACU-SLIDE TEST (K861211) | Cal-Tech Diagnostics, Inc. | 1986-11-05 |
| PREGNASLIDE (K863198) | Armkel, LLC | 1986-09-29 |
| LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) (K861703) | Leeco Diagnostics, Inc. | 1986-07-29 |
| DELFIA (TM) HCG KIT (K862044) | Lkb Instruments, Inc. | 1986-07-11 |
| DIRECT ACU-SLIDE TEST (K861212) | Cal-Tech Diagnostics, Inc. | 1986-07-07 |
| HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY (K862083) | Hygeia Sciences | 1986-07-02 |
| DIRECTACLONE CG SLIDE PREGNANCY TEST (K860945) | Pacific Biotech, Inc. | 1986-05-02 |
| TERUMO SENSIBEAD EIG HCG KIT (K854670) | Terumo Medical Corp. | 1986-02-13 |
| ACU-SLIDE-TEST (K853247) | Cal-Tech Diagnostics, Inc. | 1985-09-04 |
| DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST (K852286) | Sero-Immuno Diagnostics, Inc. | 1985-07-09 |
| PREGNANCY CARD TEST (K852066) | Em Diagnostic Systems, Inc. | 1985-06-25 |
| PRECO PREGNANCY RAPID CARD TEST, HEM #2028 (K850604) | Preco, Inc. | 1985-04-08 |
| FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES (K844346) | Fisher Diagnostics | 1985-03-04 |
| ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN (K844914) | Abbott Laboratories | 1985-02-12 |
| FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT (K844347) | Fisher Diagnostics | 1985-01-23 |
| STANBIO QUICK-TELL MONOCLONAL INDIRECT (K842544) | Stanbio Laboratory | 1984-09-21 |
| DUOCLON COLOR-CEPT (K842314) | Organon, Inc. | 1984-08-24 |
| BETA-HCG HEMAGGLUTINATION TEST (K842181) | Sero-Immuno Diagnostics, Inc. | 1984-08-22 |
| SLIDE PREGNANCY TEST (K842110) | Immunostics Co., Inc. | 1984-07-12 |
| PREG-BETA ONE HOUR TUBE TEST (K841853) | Intl. Diagnostic, Inc. | 1984-06-22 |
| PREG BETA BLUS SLIDE (K840833) | Intl. Diagnostic, Inc. | 1984-05-30 |
| PLUS URINE HCG ASSAY (K840738) | Monoclonal Antibodies, Inc. | 1984-04-19 |
| B-NEOCEPT 30 (K840650) | Organon, Inc. | 1984-04-04 |
| BHCG-CHECK (K834346) | Diagnostic Technology, Inc. | 1984-02-04 |
| FERTITUBE PREGNANCY TEST #1120 (K832867) | Stanbio Laboratory | 1984-02-03 |
| ORTHO B-HCG SLIDE TEST FOR PREGNANCY (K833137) | Ortho Diagnostic Systems, Inc. | 1984-01-18 |
| PREGNASTICK URINE HCG KIT (K833504) | Monoclonal Antibodies, Inc. | 1984-01-09 |
| QUIDEL HCG ENZYME IMMUNOASSAY KIT (K833156) | Quidel Corp. | 1983-11-25 |
| PREGNA-TEC (K832918) | Medilab Corp. | 1983-11-03 |
| B-SLIDE PREGNATE PREGNANCY TEST KIT (K832879) | Fisher Scientific Co., LLC | 1983-10-28 |
| QUICK-TELL INDIRECT PREGNANCY TEST (K832640) | Stanbio Laboratory | 1983-10-04 |
| EARLY IN HOME PREGNANCY TEST (K832599) | Warner-Lambert Co. | 1983-09-20 |
| FERTITELL DIRECT PREGNANCY TEST #1100 (K832557) | Stanbio Laboratory | 1983-09-12 |
| PREGNA-TEC (K832527) | Medilab Corp. | 1983-09-12 |
| GAMMA SLIDE TEST FOR PREGNANCY (K832473) | Gamma Biologicals, Inc. | 1983-08-16 |
| UCG-BETA SLIDE MONOCLONAL (K831775) | Armkel, LLC | 1983-08-11 |
| E.P.T. PLUS TM (K831535) | Warner-Lambert Co. | 1983-06-30 |
| EVENT-TEST SLIDE (K831383) | Icl Scientific | 1983-06-22 |
| B HCG-CHECK (K831468) | Diagnostic Technology, Inc. | 1983-06-22 |
| HCG-CHECK (K831466) | Diagnostic Technology, Inc. | 1983-06-22 |
| NEO-PREGNOSTICON DUOCLON TUBE TEST (K831339) | Organon, Inc. | 1983-06-08 |
| BETA-PREG (K831361) | Catheter Technology Corp. | 1983-06-02 |
| TESTCORP PREG (K831366) | Catheter Technology Corp. | 1983-06-02 |
| B-CLONE HCG ASSAY (K831155) | Monoclonal Antibodies, Inc. | 1983-06-02 |
| PREGNA-CERT, SLIDE PREGNANCY TEST (K831180) | Diagnostic Specialties | 1983-05-27 |
| BTC URINE LCG ASSAY (K831125) | Btc Diagnostics, Inc. | 1983-05-05 |
| HCG SCREENING TEST (K830156) | Tago, Inc. | 1983-02-09 |
| BETA FFIRM TEST (K823682) | Organon, Inc. | 1983-01-07 |
| PREG-PHILE B (K821676) | Bio Diagnostic Systems, Inc. | 1982-07-16 |
| PREG-KNOW (K821552) | Immuno Pathology Labs | 1982-06-11 |
| PREG/TEX PREGNANCY TEST (K821387) | Texas Immunology, Inc. | 1982-06-02 |
| A-1 TEST (K812788) | C.F. Medical, Inc. | 1981-12-17 |
| ACU-SLIDE TEST (K812789) | C.F. Medical, Inc. | 1981-12-17 |
| ACCURATE BETA (K812967) | Organon, Inc. | 1981-11-06 |
| ANSWER (R) (K812924) | Armkel, LLC | 1981-11-02 |
| B-NEOCEPT (K812334) | Organon, Inc. | 1981-09-01 |
| ACCURATE I (K812261) | Organon, Inc. | 1981-08-31 |
| OREIA II, B-HCG (K811940) | Organon, Inc. | 1981-08-03 |
| NEOCEPT (K811941) | Organon, Inc. | 1981-07-27 |
| FACT* HOME PREGNANCY TEST (K810581) | Ortho Pharmaceutical Corp. | 1981-03-17 |
| RAPI-DOT (K802974) | Organon, Inc. | 1980-12-19 |
| ANSWER AT-HOME PREGNANCY TEST KIT (K802660) | Armkel, LLC | 1980-11-24 |
| GESTATE SLIDE EIKEN KIT AGG. METHOD HUM (K802450) | Syn-Kit, Inc. | 1980-10-31 |
| UCG-BETA SLIDE (K802435) | Armkel, LLC | 1980-10-23 |
| UCG-BETA STAT (K802421) | Armkel, LLC | 1980-10-23 |
| PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO (K802343) | Intl. Diagnostic, Inc. | 1980-10-10 |
| IN-HOME EARLY PREGNANCY TEST KIT (K802334) | Health Diagnostics Corp. | 1980-10-10 |
| H-I-M-TEST FOR DETECTING HUMAN CHOR. GON (K800055) | Technam, Inc. | 1980-01-29 |
| SENSI-SLIDE (K792657) | Hoffmann-La Roche, Inc. | 1980-01-16 |
| PREGTELL I (K792027) | Central Biological Co. | 1979-10-30 |
| BE-SURE (K791706) | Precision Products Corp. | 1979-10-17 |
| BE-SURE (K791609) | Biologics Intl., Inc. | 1979-10-02 |
| UCG-LYPHOTEST (K791309) | Wampole Laboratories | 1979-07-30 |
| PREG-TEX (K790898) | Biologics Intl., Inc. | 1979-07-30 |
| PREGNOSTICON PREGNANCY TEST KIT (K790734) | Organon, Inc. | 1979-06-15 |
| SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 (K782166) | Ortho Diagnostics, Inc. | 1979-04-04 |
| PREGNANCY, SENSIDEX TUBE TEST (K782063) | Ortho Diagnostics, Inc. | 1979-04-04 |
| SENSI-TEX (K790267) | Hoffmann-La Roche, Inc. | 1979-03-21 |
| PREGNANCY TEST KIT, DAISY 2 IN HOME (K790002) | Boehringer Mannheim Corp. | 1979-02-01 |
| ACU-TEST IN-HOME PREGNANCY TEST (K781049) | Williams, the J.B. Co., Inc. | 1978-06-29 |
| PREGNANCY TEST KIT (K771514) | Generic Laboratory, Ltd. | 1977-09-12 |