JHI
375 FDA 510(k) clearances · Product code
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT (K842692) | Quidel Corp. | 1984-09-05 |
| TANDEM FAST VISUAL HCG ASSAY KIT - (K842633) | Hybritech, Inc. | 1984-08-23 |
| STAR HCG MONOCLONAL ANTIBODY IMMUNO (K842598) | Syncor Intl. Corp. | 1984-07-26 |
| BHCG RIA (K841854) | Syncor Intl. Corp. | 1984-06-22 |
| CA-1511, IN VITRO RADIOIMMUNOASSAY (K841821) | Travenol Laboratories, S.A. | 1984-06-22 |
| OREIA II B-HCG PREGNANCY TEST KIT (K841525) | Organon, Inc. | 1984-06-05 |
| VENTREZYME BETA-HCG IMMUNOASSAY HCG (K841081) | Ventrex Laboratories, Inc. | 1984-05-07 |
| COATED TUBE HCG IMMUNOASSAY HCG (K841023) | Ventrex Laboratories, Inc. | 1984-05-01 |
| PHASE II HCG KIT (K840328) | Medical & Scientific Designs, Inc. | 1984-04-19 |
| HCG RIA (K833851) | Syncor Intl. Corp. | 1984-03-19 |
| TANDEM VISUAL HCG IMMUNOENZYMETRIC (K834000) | Hybritech, Inc. | 1984-02-03 |
| VENTREX PREGNANCY TEST KIT ENZYME (K833960) | Vxr, Inc. | 1984-02-03 |
| STAR HCG MONOCLONAL ANTIBODY IMMUNORAD (K832796) | Syncor Intl. Corp. | 1984-01-24 |
| TANDEM R-TOTAL B-GCG KIT (K833194) | Hybritech, Inc. | 1984-01-18 |
| OREIA II B-HCG, ENZYME INNUNOASSAY (K832801) | Organon, Inc. | 1983-12-08 |
| MODIFIED CHORIO-SHURE (K832892) | Nuclear Medical Laboratories, Inc. | 1983-10-28 |
| SERUM HCG ASSAY (K832562) | Monoclonal Antibodies, Inc. | 1983-09-12 |
| HCG ACCU-STICK (K831604) | Btc Diagnostics, Inc. | 1983-07-19 |
| PBI BHCG RIA KIT (K831302) | Pacific Biotech, Inc. | 1983-06-08 |
| BHCG RIA KIT (K831264) | Micromedic Systems | 1983-06-08 |
| ARIA II I-HCG (K830997) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-06-02 |
| RIAGEN B-HCG RIA KIT (K831221) | Biogenex Laboratories | 1983-06-02 |
| DUOCLON SLIDE TEST (K831109) | Organon, Inc. | 1983-06-02 |
| BETA-QUIK-15 RIA KIT (K831223) | Pacific Biotech, Inc. | 1983-06-02 |
| B-GCG SYSTEM BY RIA (K830526) | Pcl-Ria, Inc. | 1983-04-05 |
| BETA-COTE B-HCG PREGNANCY SCREENING SYS (K830695) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-03-29 |
| DAC-CEL DIAGNATAL RD 50 (K830203) | Wellcome Diagnostics | 1983-02-18 |
| TANDEM E GCG VISUAL END POINT INNUMOENZ (K830138) | Hybritech, Inc. | 1983-02-07 |
| GENESIS B-HCG (K823753) | Armkel, LLC | 1983-01-24 |
| IN VITRO GAMMACOAT B-HCG RADIO. TEST (K823313) | Clinical Assays, Inc. | 1982-12-22 |
| RADIOIMMUNOASSAY, HUMAN CHORRIONIC (K822840) | Bioclinical Group | 1982-10-27 |
| MODEL UCG ASSAY (K822520) | Monoclonal Antibodies, Inc. | 1982-09-28 |
| B-HCG RADIOIMMUNOASSAY KIT (K822515) | Bioclinical Group | 1982-09-14 |
| B-HCG (K822343) | Diagnostic Products Corp. | 1982-09-02 |
| HCG BETA RIA KIT (K822152) | Clinetics Corp. | 1982-09-02 |
| TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT (K821944) | Hybritech, Inc. | 1982-07-22 |
| RIAGEN B-HCG RIA (K821657) | Biogenex Laboratories | 1982-07-13 |
| RIAGEN B-HCG RIA (K821234) | Biogenex Laboratories | 1982-05-21 |
| ROCHE(R) B-HCG RIA URINE STANDARD (K820942) | Hoffmann-La Roche, Inc. | 1982-05-03 |
| AMERLEX B-LCG RIA KIT (K821031) | Amersham Corp. | 1982-05-03 |
| TANDEM HCG KIT (K820822) | Hybritech, Inc. | 1982-04-29 |
| ROCHE B-HCG STANDARDS (K820614) | Hoffmann-La Roche, Inc. | 1982-04-01 |
| ROCHE B-HCG RIA (K820613) | Hoffmann-La Roche, Inc. | 1982-04-01 |
| CHORIO-QUANT (K820523) | Nuclear Medical Laboratories, Inc. | 1982-03-15 |
| IMMOPHASE B HCG RADIOIMMUNOASSAY (K820321) | Corning Medical & Scientific | 1982-03-11 |
| ABBOTT LABORATORIES B-HCG EIA (K820271) | Abbott Laboratories | 1982-03-11 |
| TANDEM QUALITATIVE HCG KIT (K812461) | Hybritech, Inc. | 1981-10-13 |
| CONCEP-7-BHCG (K812156) | Leeco Diagnostics, Inc. | 1981-08-20 |
| HCG RADIOIMMUNOASSAY KIT (125I) (K811421) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-07-10 |
| EARLY PREGNANCY DETECTION (K811398) | Immuchem Corp. | 1981-05-29 |
| HCG RADIOIMMUNOASSAY (K811116) | Hoffmann-La Roche, Inc. | 1981-05-13 |
| DAC-CEL HCG (K810215) | Burroughs Wellcome Co. | 1981-04-17 |
| CHORIO-SHURE (K810936) | Nuclear Medical Laboratories, Inc. | 1981-04-17 |
| DAC-CEL DIAGNATAL (K810214) | Burroughs Wellcome Co. | 1981-03-06 |
| BETA-TEC QUALITATIVE (K802999) | Armkel, LLC | 1980-12-22 |
| MRI HCG-BETA RIA KIT CAT. #MR-10100 (K801491) | Microanalytic Research, Inc. | 1980-08-13 |
| GAMMADAB B-HCG RADIOIMMUNOASSAY KIT (K801409) | Travenol Laboratories, S.A. | 1980-07-14 |
| ROCHE HCG STANDARDS (K801244) | Hoffmann-La Roche, Inc. | 1980-06-20 |
| CONCEP-7-BHCG (K792308) | Leeco Diagnostics, Inc. | 1979-12-06 |
| HUMAN CHORIONIC GONADOTROPIN (RIA) (K792197) | Nuclear Medical Laboratories, Inc. | 1979-12-06 |
| HCG RIA PREGNANCY TEST (K791206) | Hoffmann-La Roche, Inc. | 1979-07-30 |
| RABBIT ANTISERUM TO HUMAN CHORIONIC (K790864) | Pcl-Ria, Inc. | 1979-07-17 |
| HUMAN CHORIONIC GONADOTROPHIN STANDARDS (K790863) | Pcl-Ria, Inc. | 1979-07-17 |
| LABELED HUMAN CHORIONIC GONADOTROPHIN (K790876) | Pcl-Ria, Inc. | 1979-07-17 |
| CONCEP-7-B-HCG (K790397) | Leeco Diagnostics, Inc. | 1979-05-23 |
| CHORIC-SHURE (K790138) | Nuclear Medical Laboratories, Inc. | 1979-03-12 |
| BETA-TEC (K781794) | Wampole Laboratories | 1978-12-29 |
| RIA KIT, PREG-STAT (K781733) | Serono Laboratories, Inc. | 1978-12-20 |
| EARLY PREGNANCY DETECTION KIT (K781487) | Radioassay Systems Laboratories, Inc. | 1978-10-11 |
| RIA QUANT B-HCG TEST KIT (K781578) | Mallinckrodt Critical Care | 1978-10-10 |
| HUMAN CHORIONIC GONADO.-BETA RIA KIT (K781310) | Diagnostics Biochem Canada, Inc. | 1978-08-31 |
| B-HCG-RIA (K780679) | Nuclear Medical Systems, Inc. | 1978-06-14 |
| QUANTROLS HCG (K772086) | Organon, Inc. | 1977-11-23 |
| BETA-HCG RIA (K772039) | Monitor Science Corp. | 1977-11-23 |
| BIOCEPT-G (K760336) | Wampole Laboratories | 1976-11-12 |
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