510(k) K900688 ยท LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
| Applicant | Clinical Sciences, Inc., Whippany NJ, US |
| Decision | Substantially Equivalent, May 15, 1990 |
| Received | Feb 13, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900688
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2005 | Diasorin Inc. Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285 Terminated |
LFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.