FDA Product Code
FDA Product Code JHJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1155
510(k) Clearances — 96 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972606 | PREGNACOL PREGNANCY TEST | Immunostics Inc., | 1997-08-29 | Traditional | PDF ↗ |
| K921968 | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST | Tech-Co, Inc. | 1996-06-28 | Traditional | PDF ↗ |
| K935863 | SAS(TM) DIRECT MONOCLONAL HCG | Sa Scientific, Inc. | 1994-02-24 | Traditional | PDF ↗ |
| K926112 | ACCUTEX BETA-HCG TEST | J.S. Medical Assoc. | 1993-07-28 | Traditional | PDF ↗ |
| K930609 | SAS(TM) MONOCLONAL HCG-SLIDE | Sa Scientific, Inc. | 1993-03-29 | Traditional | PDF ↗ |
| K920716 | DIRECT PREGNANCY TEST | Tech-Co, Inc. | 1992-03-24 | Traditional | PDF ↗ |
| K910946 | CLEARVIEW HCG | Unipath , Ltd. | 1991-04-01 | Traditional | PDF ↗ |
| K881435 | PREGNOSPIA II | Organon Teknika Corp. | 1988-05-27 | Traditional | PDF ↗ |
| K880163 | PREGNANCY (HCG) CARD & LIQUID TEST | Ampcor, Inc. | 1988-05-17 | Traditional | PDF ↗ |
| K880478 | PREGNANCY BETA-HCG CARD & LIQUID TEST | Ampcor, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K880328 | HCG-NOSTICK | Organon Teknika Corp. | 1988-03-15 | Traditional | PDF ↗ |
| K875262 | V-TREND BETA-HCG DRY-SPOT TEST | Texas Immunology, Inc. | 1988-02-02 | Traditional | PDF ↗ |
| K874638 | V-TREND BETA-HCG TEST | Texas Immunology, Inc. | 1988-01-21 | Traditional | PDF ↗ |
| K871294 | ACU-PREG-AL SLIDE TEST | Papibris Scientific, Inc. | 1987-05-12 | Traditional | PDF ↗ |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | Immunostics Co., Inc. | 1986-11-13 | Traditional | PDF ↗ |
| K861211 | MONO ACU-SLIDE TEST | Cal-Tech Diagnostics, Inc. | 1986-11-05 | Traditional | PDF ↗ |
| K863198 | PREGNASLIDE | Armkel, LLC | 1986-09-29 | Traditional | PDF ↗ |
| K861703 | LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) | Leeco Diagnostics, Inc. | 1986-07-29 | Traditional | PDF ↗ |
| K862044 | DELFIA (TM) HCG KIT | Lkb Instruments, Inc. | 1986-07-11 | Traditional | PDF ↗ |
| K861212 | DIRECT ACU-SLIDE TEST | Cal-Tech Diagnostics, Inc. | 1986-07-07 | Traditional | PDF ↗ |
| K862083 | HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY | Hygeia Sciences | 1986-07-02 | Traditional | PDF ↗ |
| K860945 | DIRECTACLONE CG SLIDE PREGNANCY TEST | Pacific Biotech, Inc. | 1986-05-02 | Traditional | PDF ↗ |
| K854670 | TERUMO SENSIBEAD EIG HCG KIT | Terumo Medical Corp. | 1986-02-13 | Traditional | PDF ↗ |
| K853247 | ACU-SLIDE-TEST | Cal-Tech Diagnostics, Inc. | 1985-09-04 | Traditional | PDF ↗ |
| K852286 | DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST | Sero-Immuno Diagnostics, Inc. | 1985-07-09 | Traditional | PDF ↗ |
| K852066 | PREGNANCY CARD TEST | Em Diagnostic Systems, Inc. | 1985-06-25 | Traditional | PDF ↗ |
| K850604 | PRECO PREGNANCY RAPID CARD TEST, HEM #2028 | Preco, Inc. | 1985-04-08 | Traditional | PDF ↗ |
| K844346 | FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES | Fisher Diagnostics | 1985-03-04 | Traditional | PDF ↗ |
| K844914 | ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN | Abbott Laboratories | 1985-02-12 | Traditional | PDF ↗ |
| K844347 | FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT | Fisher Diagnostics | 1985-01-23 | Traditional | PDF ↗ |
| K842544 | STANBIO QUICK-TELL MONOCLONAL INDIRECT | Stanbio Laboratory | 1984-09-21 | Traditional | PDF ↗ |
| K842314 | DUOCLON COLOR-CEPT | Organon, Inc. | 1984-08-24 | Traditional | PDF ↗ |
| K842181 | BETA-HCG HEMAGGLUTINATION TEST | Sero-Immuno Diagnostics, Inc. | 1984-08-22 | Traditional | PDF ↗ |
| K842110 | SLIDE PREGNANCY TEST | Immunostics Co., Inc. | 1984-07-12 | Traditional | PDF ↗ |
| K841853 | PREG-BETA ONE HOUR TUBE TEST | Intl. Diagnostic, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K840833 | PREG BETA BLUS SLIDE | Intl. Diagnostic, Inc. | 1984-05-30 | Traditional | PDF ↗ |
| K840738 | PLUS URINE HCG ASSAY | Monoclonal Antibodies, Inc. | 1984-04-19 | Traditional | PDF ↗ |
| K840650 | B-NEOCEPT 30 | Organon, Inc. | 1984-04-04 | Traditional | PDF ↗ |
| K834346 | BHCG-CHECK | Diagnostic Technology, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K832867 | FERTITUBE PREGNANCY TEST #1120 | Stanbio Laboratory | 1984-02-03 | Traditional | PDF ↗ |
| K833137 | ORTHO B-HCG SLIDE TEST FOR PREGNANCY | Ortho Diagnostic Systems, Inc. | 1984-01-18 | Traditional | PDF ↗ |
| K833504 | PREGNASTICK URINE HCG KIT | Monoclonal Antibodies, Inc. | 1984-01-09 | Traditional | PDF ↗ |
| K833156 | QUIDEL HCG ENZYME IMMUNOASSAY KIT | Quidel Corp. | 1983-11-25 | Traditional | PDF ↗ |
| K832918 | PREGNA-TEC | Medilab Corp. | 1983-11-03 | Traditional | PDF ↗ |
| K832879 | B-SLIDE PREGNATE PREGNANCY TEST KIT | Fisher Scientific Co., LLC | 1983-10-28 | Traditional | PDF ↗ |
| K832640 | QUICK-TELL INDIRECT PREGNANCY TEST | Stanbio Laboratory | 1983-10-04 | Traditional | PDF ↗ |
| K832599 | EARLY IN HOME PREGNANCY TEST | Warner-Lambert Co. | 1983-09-20 | Traditional | PDF ↗ |
| K832557 | FERTITELL DIRECT PREGNANCY TEST #1100 | Stanbio Laboratory | 1983-09-12 | Traditional | PDF ↗ |
| K832527 | PREGNA-TEC | Medilab Corp. | 1983-09-12 | Traditional | PDF ↗ |
| K832473 | GAMMA SLIDE TEST FOR PREGNANCY | Gamma Biologicals, Inc. | 1983-08-16 | Traditional | PDF ↗ |
| K831775 | UCG-BETA SLIDE MONOCLONAL | Armkel, LLC | 1983-08-11 | Traditional | PDF ↗ |
| K831535 | E.P.T. PLUS TM | Warner-Lambert Co. | 1983-06-30 | Traditional | PDF ↗ |
| K831466 | HCG-CHECK | Diagnostic Technology, Inc. | 1983-06-22 | Traditional | PDF ↗ |
| K831383 | EVENT-TEST SLIDE | Icl Scientific | 1983-06-22 | Traditional | PDF ↗ |
| K831468 | B HCG-CHECK | Diagnostic Technology, Inc. | 1983-06-22 | Traditional | PDF ↗ |
| K831339 | NEO-PREGNOSTICON DUOCLON TUBE TEST | Organon, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K831361 | BETA-PREG | Catheter Technology Corp. | 1983-06-02 | Traditional | PDF ↗ |
| K831155 | B-CLONE HCG ASSAY | Monoclonal Antibodies, Inc. | 1983-06-02 | Traditional | PDF ↗ |
| K831366 | TESTCORP PREG | Catheter Technology Corp. | 1983-06-02 | Traditional | PDF ↗ |
| K831180 | PREGNA-CERT, SLIDE PREGNANCY TEST | Diagnostic Specialties | 1983-05-27 | Traditional | PDF ↗ |
| K831125 | BTC URINE LCG ASSAY | Btc Diagnostics, Inc. | 1983-05-05 | Traditional | PDF ↗ |
| K830156 | HCG SCREENING TEST | Tago, Inc. | 1983-02-09 | Traditional | PDF ↗ |
| K823682 | BETA FFIRM TEST | Organon, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K821676 | PREG-PHILE B | Bio Diagnostic Systems, Inc. | 1982-07-16 | Traditional | PDF ↗ |
| K821552 | PREG-KNOW | Immuno Pathology Labs | 1982-06-11 | Traditional | PDF ↗ |
| K821387 | PREG/TEX PREGNANCY TEST | Texas Immunology, Inc. | 1982-06-02 | Traditional | PDF ↗ |
| K812789 | ACU-SLIDE TEST | C.F. Medical, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K812788 | A-1 TEST | C.F. Medical, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K812967 | ACCURATE BETA | Organon, Inc. | 1981-11-06 | Traditional | PDF ↗ |
| K812924 | ANSWER (R) | Armkel, LLC | 1981-11-02 | Traditional | PDF ↗ |
| K812334 | B-NEOCEPT | Organon, Inc. | 1981-09-01 | Traditional | PDF ↗ |
| K812261 | ACCURATE I | Organon, Inc. | 1981-08-31 | Traditional | PDF ↗ |
| K811940 | OREIA II, B-HCG | Organon, Inc. | 1981-08-03 | Traditional | PDF ↗ |
| K811941 | NEOCEPT | Organon, Inc. | 1981-07-27 | Traditional | PDF ↗ |
| K810581 | FACT* HOME PREGNANCY TEST | Ortho Pharmaceutical Corp. | 1981-03-17 | Traditional | PDF ↗ |
| K802974 | RAPI-DOT | Organon, Inc. | 1980-12-19 | Traditional | PDF ↗ |
| K802660 | ANSWER AT-HOME PREGNANCY TEST KIT | Armkel, LLC | 1980-11-24 | Traditional | PDF ↗ |
| K802450 | GESTATE SLIDE EIKEN KIT AGG. METHOD HUM | Syn-Kit, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K802421 | UCG-BETA STAT | Armkel, LLC | 1980-10-23 | Traditional | PDF ↗ |
| K802435 | UCG-BETA SLIDE | Armkel, LLC | 1980-10-23 | Traditional | PDF ↗ |
| K802343 | PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO | Intl. Diagnostic, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K802334 | IN-HOME EARLY PREGNANCY TEST KIT | Health Diagnostics Corp. | 1980-10-10 | Traditional | PDF ↗ |
| K800055 | H-I-M-TEST FOR DETECTING HUMAN CHOR. GON | Technam, Inc. | 1980-01-29 | Traditional | PDF ↗ |
| K792657 | SENSI-SLIDE | Hoffmann-La Roche, Inc. | 1980-01-16 | Traditional | PDF ↗ |
| K792027 | PREGTELL I | Central Biological Co. | 1979-10-30 | Traditional | PDF ↗ |
| K791706 | BE-SURE | Precision Products Corp. | 1979-10-17 | Traditional | PDF ↗ |
| K791609 | BE-SURE | Biologics Intl., Inc. | 1979-10-02 | Traditional | PDF ↗ |
| K790898 | PREG-TEX | Biologics Intl., Inc. | 1979-07-30 | Traditional | PDF ↗ |
| K791309 | UCG-LYPHOTEST | Wampole Laboratories | 1979-07-30 | Traditional | PDF ↗ |
| K790734 | PREGNOSTICON PREGNANCY TEST KIT | Organon, Inc. | 1979-06-15 | Traditional | PDF ↗ |
| K782063 | PREGNANCY, SENSIDEX TUBE TEST | Ortho Diagnostics, Inc. | 1979-04-04 | Traditional | PDF ↗ |
| K782166 | SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 | Ortho Diagnostics, Inc. | 1979-04-04 | Traditional | PDF ↗ |
| K790267 | SENSI-TEX | Hoffmann-La Roche, Inc. | 1979-03-21 | Traditional | PDF ↗ |
| K790002 | PREGNANCY TEST KIT, DAISY 2 IN HOME | Boehringer Mannheim Corp. | 1979-02-01 | Traditional | PDF ↗ |
| K781049 | ACU-TEST IN-HOME PREGNANCY TEST | Williams, the J.B. Co., Inc. | 1978-06-29 | Traditional | PDF ↗ |
| K771514 | PREGNANCY TEST KIT | Generic Laboratory, Ltd. | 1977-09-12 | Traditional | PDF ↗ |
Product code JHJ · Class II · Clinical Chemistry. Data: openFDA.