Panels › Clinical Chemistry › Product code JHI · Class 2
Visual, Pregnancy Hcg, Prescription Use
Regulation 862.1155
1510(k)s in 12 months (376 all time)
4recalls in 12 months (47 all time)
34recalls that name a 510(k)
Top companies in JHI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 1984 | K842499 | NMS 1043 ENZYME IMMUNOASSAY KIT Nms Pharmaceuticals, Inc. | JHI |
| Sep 5, 1984 | K842692 | QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT Quidel Corp. | JHI |
| Aug 23, 1984 | K842633 | TANDEM FAST VISUAL HCG ASSAY KIT - Hybritech, Inc. | JHI |
| Jul 26, 1984 | K842598 | STAR HCG MONOCLONAL ANTIBODY IMMUNO Syncor Intl. Corp. | JHI |
| Jun 22, 1984 | K841854 | BHCG RIA Syncor Intl. Corp. | JHI |
| Jun 22, 1984 | K841821 | CA-1511, IN VITRO RADIOIMMUNOASSAY Travenol Laboratories, S.A. | JHI |
| Jun 5, 1984 | K841525 | OREIA II B-HCG PREGNANCY TEST KIT Organon, Inc. | JHI |
| May 7, 1984 | K841081 | VENTREZYME BETA-HCG IMMUNOASSAY HCG Ventrex Laboratories, Inc. | JHI |
| May 1, 1984 | K841023 | COATED TUBE HCG IMMUNOASSAY HCG Ventrex Laboratories, Inc. | JHI |
| Apr 19, 1984 | K840328 | PHASE II HCG KIT Medical & Scientific Designs, Inc. | JHI |
| Mar 19, 1984 | K833851 | HCG RIA Syncor Intl. Corp. | JHI |
| Feb 3, 1984 | K834000 | TANDEM VISUAL HCG IMMUNOENZYMETRIC Hybritech, Inc. | JHI |
| Feb 3, 1984 | K833960 | VENTREX PREGNANCY TEST KIT ENZYME Vxr, Inc. | JHI |
| Jan 24, 1984 | K832796 | STAR HCG MONOCLONAL ANTIBODY IMMUNORAD Syncor Intl. Corp. | JHI |
| Jan 18, 1984 | K833194 | TANDEM R-TOTAL B-GCG KIT Hybritech, Inc. | JHI |
| Dec 8, 1983 | K832801 | OREIA II B-HCG, ENZYME INNUNOASSAY Organon, Inc. | JHI |
| Oct 28, 1983 | K832892 | MODIFIED CHORIO-SHURE Nuclear Medical Laboratories, Inc. | JHI |
| Sep 12, 1983 | K832562 | SERUM HCG ASSAY Monoclonal Antibodies, Inc. | JHI |
| Jul 19, 1983 | K831604 | HCG ACCU-STICK Btc Diagnostics, Inc. | JHI |
| Jun 8, 1983 | K831302 | PBI BHCG RIA KIT Pacific Biotech, Inc. | JHI |
| Jun 8, 1983 | K831264 | BHCG RIA KIT Micromedic Systems | JHI |
| Jun 2, 1983 | K831223 | BETA-QUIK-15 RIA KIT Pacific Biotech, Inc. | JHI |
| Jun 2, 1983 | K831221 | RIAGEN B-HCG RIA KIT Biogenex Laboratories | JHI |
| Jun 2, 1983 | K831109 | DUOCLON SLIDE TEST Organon, Inc. | JHI |
| Jun 2, 1983 | K830997 | ARIA II I-HCG Bd Becton Dickinson Vacutainer Systems Preanalytic | JHI |
| Apr 5, 1983 | K830526 | B-GCG SYSTEM BY RIA Pcl-Ria, Inc. | JHI |
| Mar 29, 1983 | K830695 | BETA-COTE B-HCG PREGNANCY SCREENING SYS Bd Becton Dickinson Vacutainer Systems Preanalytic | JHI |
| Feb 18, 1983 | K830203 | DAC-CEL DIAGNATAL RD 50 Wellcome Diagnostics | JHI |
| Feb 7, 1983 | K830138 | TANDEM E GCG VISUAL END POINT INNUMOENZ Hybritech, Inc. | JHI |
| Jan 24, 1983 | K823753 | GENESIS B-HCG Armkel, LLC | JHI |
| Dec 22, 1982 | K823313 | IN VITRO GAMMACOAT B-HCG RADIO. TEST Clinical Assays, Inc. | JHI |
| Oct 27, 1982 | K822840 | RADIOIMMUNOASSAY, HUMAN CHORRIONIC Bioclinical Group | JHI |
| Sep 28, 1982 | K822520 | MODEL UCG ASSAY Monoclonal Antibodies, Inc. | JHI |
| Sep 14, 1982 | K822515 | B-HCG RADIOIMMUNOASSAY KIT Bioclinical Group | JHI |
| Sep 2, 1982 | K822343 | B-HCG Diagnostic Products Corp. | JHI |
| Sep 2, 1982 | K822152 | HCG BETA RIA KIT Clinetics Corp. | JHI |
| Jul 22, 1982 | K821944 | TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT Hybritech, Inc. | JHI |
| Jul 13, 1982 | K821657 | RIAGEN B-HCG RIA Biogenex Laboratories | JHI |
| May 21, 1982 | K821234 | RIAGEN B-HCG RIA Biogenex Laboratories | JHI |
| May 3, 1982 | K821031 | AMERLEX B-LCG RIA KIT Amersham Corp. | JHI |
| May 3, 1982 | K820942 | ROCHE(R) B-HCG RIA URINE STANDARD Hoffmann-La Roche, Inc. | JHI |
| Apr 29, 1982 | K820822 | TANDEM HCG KIT Hybritech, Inc. | JHI |
| Apr 1, 1982 | K820614 | ROCHE B-HCG STANDARDS Hoffmann-La Roche, Inc. | JHI |
| Apr 1, 1982 | K820613 | ROCHE B-HCG RIA Hoffmann-La Roche, Inc. | JHI |
| Mar 15, 1982 | K820523 | CHORIO-QUANT Nuclear Medical Laboratories, Inc. | JHI |
| Mar 11, 1982 | K820321 | IMMOPHASE B HCG RADIOIMMUNOASSAY Corning Medical & Scientific | JHI |
| Mar 11, 1982 | K820271 | ABBOTT LABORATORIES B-HCG EIA Abbott Laboratories | JHI |
| Oct 13, 1981 | K812461 | TANDEM QUALITATIVE HCG KIT Hybritech, Inc. | JHI |
| Aug 20, 1981 | K812156 | CONCEP-7-BHCG Leeco Diagnostics, Inc. | JHI |
| Jul 10, 1981 | K811421 | HCG RADIOIMMUNOASSAY KIT (125I) Bd Becton Dickinson Vacutainer Systems Preanalytic | JHI |
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