510(k) K870521 ยท JHI Visual, Pregnancy Hcg, Prescription Use
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 8, 1987 |
| Received | Feb 6, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870521
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK HCG; Part Number: 025261
Assay, Reproductive Hormone Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.