510(k) K963133 ยท JHI Visual, Pregnancy Hcg, Prescription Use
PS-UNIT CASSETTE/SERUM HCG
| Applicant | International Newtech Development, Inc., Richmond, B.C., CA |
| Decision | Substantially Equivalent, Nov 18, 1996 |
| Received | Aug 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 Open, Classified |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.