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 |
|---|---|---|---|
| May 29, 1981 | K811398 | EARLY PREGNANCY DETECTION Immuchem Corp. | JHI |
| May 13, 1981 | K811116 | HCG RADIOIMMUNOASSAY Hoffmann-La Roche, Inc. | JHI |
| Apr 17, 1981 | K810936 | CHORIO-SHURE Nuclear Medical Laboratories, Inc. | JHI |
| Apr 17, 1981 | K810215 | DAC-CEL HCG Burroughs Wellcome Co. | JHI |
| Mar 6, 1981 | K810214 | DAC-CEL DIAGNATAL Burroughs Wellcome Co. | JHI |
| Dec 22, 1980 | K802999 | BETA-TEC QUALITATIVE Armkel, LLC | JHI |
| Aug 13, 1980 | K801491 | MRI HCG-BETA RIA KIT CAT. #MR-10100 Microanalytic Research, Inc. | JHI |
| Jul 14, 1980 | K801409 | GAMMADAB B-HCG RADIOIMMUNOASSAY KIT Travenol Laboratories, S.A. | JHI |
| Jun 20, 1980 | K801244 | ROCHE HCG STANDARDS Hoffmann-La Roche, Inc. | JHI |
| Dec 6, 1979 | K792308 | CONCEP-7-BHCG Leeco Diagnostics, Inc. | JHI |
| Dec 6, 1979 | K792197 | HUMAN CHORIONIC GONADOTROPIN (RIA) Nuclear Medical Laboratories, Inc. | JHI |
| Jul 30, 1979 | K791206 | HCG RIA PREGNANCY TEST Hoffmann-La Roche, Inc. | JHI |
| Jul 17, 1979 | K790876 | LABELED HUMAN CHORIONIC GONADOTROPHIN Pcl-Ria, Inc. | JHI |
| Jul 17, 1979 | K790864 | RABBIT ANTISERUM TO HUMAN CHORIONIC Pcl-Ria, Inc. | JHI |
| Jul 17, 1979 | K790863 | HUMAN CHORIONIC GONADOTROPHIN STANDARDS Pcl-Ria, Inc. | JHI |
| May 23, 1979 | K790397 | CONCEP-7-B-HCG Leeco Diagnostics, Inc. | JHI |
| Mar 12, 1979 | K790138 | CHORIC-SHURE Nuclear Medical Laboratories, Inc. | JHI |
| Dec 29, 1978 | K781794 | BETA-TEC Wampole Laboratories | JHI |
| Dec 20, 1978 | K781733 | RIA KIT, PREG-STAT Serono Laboratories, Inc. | JHI |
| Oct 11, 1978 | K781487 | EARLY PREGNANCY DETECTION KIT Radioassay Systems Laboratories, Inc. | JHI |
| Oct 10, 1978 | K781578 | RIA QUANT B-HCG TEST KIT Mallinckrodt Critical Care | JHI |
| Aug 31, 1978 | K781310 | HUMAN CHORIONIC GONADO.-BETA RIA KIT Diagnostics Biochem Canada, Inc. | JHI |
| Jun 14, 1978 | K780679 | B-HCG-RIA Nuclear Medical Systems, Inc. | JHI |
| Nov 23, 1977 | K772086 | QUANTROLS HCG Organon, Inc. | JHI |
| Nov 23, 1977 | K772039 | BETA-HCG RIA Monitor Science Corp. | JHI |
| Nov 12, 1976 | K760336 | BIOCEPT-G Wampole Laboratories | JHI |
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