Panels › Clinical Chemistry › Product code JHJ · Class 2
Agglutination Method, Human Chorionic Gonadotropin
Regulation 862.1155
0510(k)s in 12 months (96 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in JHJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Organon, Inc. | 11 | 0 |
| Armkel, LLC | 6 | 0 |
| Stanbio Laboratory | 4 | 0 |
| Cal-Tech Diagnostics, Inc. | 3 | 0 |
| Diagnostic Technology, Inc. | 3 | 0 |
| Immunostics Co., Inc. | 3 | 0 |
| Intl. Diagnostic, Inc. | 3 | 0 |
| Monoclonal Antibodies, Inc. | 3 | 0 |
| PerkinElmer Life and Analytical Sciences, Wallac, OY | 0 | 3 |
| Texas Immunology, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 29, 1997 | K972606 | PREGNACOL PREGNANCY TEST Immunostics Inc., | JHJ |
| Jun 28, 1996 | K921968 | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST Tech-Co, Inc. | JHJ |
| Feb 24, 1994 | K935863 | SAS(TM) DIRECT MONOCLONAL HCG Sa Scientific, Inc. | JHJ |
| Jul 28, 1993 | K926112 | ACCUTEX BETA-HCG TEST J.S. Medical Assoc. | JHJ |
| Mar 29, 1993 | K930609 | SAS(TM) MONOCLONAL HCG-SLIDE Sa Scientific, Inc. | JHJ |
| Mar 24, 1992 | K920716 | DIRECT PREGNANCY TEST Tech-Co, Inc. | JHJ |
| Apr 1, 1991 | K910946 | CLEARVIEW HCG Unipath , Ltd., GB | JHJ |
| May 27, 1988 | K881435 | PREGNOSPIA II Organon Teknika Corp. | JHJ |
| May 17, 1988 | K880163 | PREGNANCY (HCG) CARD & LIQUID TEST Ampcor, Inc. | JHJ |
| Apr 28, 1988 | K880478 | PREGNANCY BETA-HCG CARD & LIQUID TEST Ampcor, Inc. | JHJ |
| Mar 15, 1988 | K880328 | HCG-NOSTICK Organon Teknika Corp. | JHJ |
| Feb 2, 1988 | K875262 | V-TREND BETA-HCG DRY-SPOT TEST Texas Immunology, Inc. | JHJ |
| Jan 21, 1988 | K874638 | V-TREND BETA-HCG TEST Texas Immunology, Inc. | JHJ |
| May 12, 1987 | K871294 | ACU-PREG-AL SLIDE TEST Papibris Scientific, Inc. | JHJ |
| Nov 13, 1986 | K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) Immunostics Co., Inc. | JHJ |
| Nov 5, 1986 | K861211 | MONO ACU-SLIDE TEST Cal-Tech Diagnostics, Inc. | JHJ |
| Sep 29, 1986 | K863198 | PREGNASLIDE Armkel, LLC | JHJ |
| Jul 29, 1986 | K861703 | LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) Leeco Diagnostics, Inc. | JHJ |
| Jul 11, 1986 | K862044 | DELFIA (TM) HCG KIT Lkb Instruments, Inc. | JHJ |
| Jul 7, 1986 | K861212 | DIRECT ACU-SLIDE TEST Cal-Tech Diagnostics, Inc. | JHJ |
| Jul 2, 1986 | K862083 | HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY Hygeia Sciences | JHJ |
| May 2, 1986 | K860945 | DIRECTACLONE CG SLIDE PREGNANCY TEST Pacific Biotech, Inc. | JHJ |
| Feb 13, 1986 | K854670 | TERUMO SENSIBEAD EIG HCG KIT Terumo Medical Corp. | JHJ |
| Sep 4, 1985 | K853247 | ACU-SLIDE-TEST Cal-Tech Diagnostics, Inc. | JHJ |
| Jul 9, 1985 | K852286 | DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST Sero-Immuno Diagnostics, Inc. | JHJ |
| Jun 25, 1985 | K852066 | PREGNANCY CARD TEST Em Diagnostic Systems, Inc. | JHJ |
| Apr 8, 1985 | K850604 | PRECO PREGNANCY RAPID CARD TEST, HEM #2028 Preco, Inc. | JHJ |
| Mar 4, 1985 | K844346 | FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES Fisher Diagnostics | JHJ |
| Feb 12, 1985 | K844914 | ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN Abbott Laboratories | JHJ |
| Jan 23, 1985 | K844347 | FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT Fisher Diagnostics | JHJ |
| Sep 21, 1984 | K842544 | STANBIO QUICK-TELL MONOCLONAL INDIRECT Stanbio Laboratory | JHJ |
| Aug 24, 1984 | K842314 | DUOCLON COLOR-CEPT Organon, Inc. | JHJ |
| Aug 22, 1984 | K842181 | BETA-HCG HEMAGGLUTINATION TEST Sero-Immuno Diagnostics, Inc. | JHJ |
| Jul 12, 1984 | K842110 | SLIDE PREGNANCY TEST Immunostics Co., Inc. | JHJ |
| Jun 22, 1984 | K841853 | PREG-BETA ONE HOUR TUBE TEST Intl. Diagnostic, Inc. | JHJ |
| May 30, 1984 | K840833 | PREG BETA BLUS SLIDE Intl. Diagnostic, Inc. | JHJ |
| Apr 19, 1984 | K840738 | PLUS URINE HCG ASSAY Monoclonal Antibodies, Inc. | JHJ |
| Apr 4, 1984 | K840650 | B-NEOCEPT 30 Organon, Inc. | JHJ |
| Feb 4, 1984 | K834346 | BHCG-CHECK Diagnostic Technology, Inc. | JHJ |
| Feb 3, 1984 | K832867 | FERTITUBE PREGNANCY TEST #1120 Stanbio Laboratory | JHJ |
| Jan 18, 1984 | K833137 | ORTHO B-HCG SLIDE TEST FOR PREGNANCY Ortho Diagnostic Systems, Inc. | JHJ |
| Jan 9, 1984 | K833504 | PREGNASTICK URINE HCG KIT Monoclonal Antibodies, Inc. | JHJ |
| Nov 25, 1983 | K833156 | QUIDEL HCG ENZYME IMMUNOASSAY KIT Quidel Corp. | JHJ |
| Nov 3, 1983 | K832918 | PREGNA-TEC Medilab Corp. | JHJ |
| Oct 28, 1983 | K832879 | B-SLIDE PREGNATE PREGNANCY TEST KIT Fisher Scientific Co., LLC | JHJ |
| Oct 4, 1983 | K832640 | QUICK-TELL INDIRECT PREGNANCY TEST Stanbio Laboratory | JHJ |
| Sep 20, 1983 | K832599 | EARLY IN HOME PREGNANCY TEST Warner-Lambert Co. | JHJ |
| Sep 12, 1983 | K832557 | FERTITELL DIRECT PREGNANCY TEST #1100 Stanbio Laboratory | JHJ |
| Sep 12, 1983 | K832527 | PREGNA-TEC Medilab Corp. | JHJ |
| Aug 16, 1983 | K832473 | GAMMA SLIDE TEST FOR PREGNANCY Gamma Biologicals, Inc. | JHJ |
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