510(k) K961965 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
SURE CHECK PREGNANCY TEST
| Applicant | Chembio Diagnostic Systems, Inc., Great Neck, NY, US |
| Decision | Substantially Equivalent, Jun 24, 1996 |
| Received | May 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961965
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2004 | Chembio Diagnostic System Inc OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal Terminated |
LCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.