510(k) K983886 ยท LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
POCKIT HSV 2 RAPID TEST
| Applicant | Diagnology , Ltd., West Cadwell NJ, US |
| Decision | Substantially Equivalent, Aug 19, 1999 |
| Received | Nov 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983886
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2023 | Biokit, S.A. biokitHSV-2 Rapid Test, REF: 300028001 Open, Classified |
LGC | None listed |
| Jul 8, 2010 | Biokit U.S.A. Inc. Biokit HSV-2 Rapid test Catalogue Number: 3000-28001.
20 test Kit.
In Vitro Diagnostic test for Herpes Simplex Virus 2. Terminated |
LGC | None listed |
| Jul 8, 2010 | Biokit U.S.A. Inc. Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395.
20 test Kit
In Vitro Diagnostic test for Herpes Simplex Virus 2 Terminated |
LGC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.