510(k) K883427 ยท GQX Antiserum, Cf, Varicella-Zoster
VIRGO(R) VZV-IGG ELISA
| Applicant | Electro-Nucleonics, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Mar 10, 1989 |
| Received | Aug 15, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883427
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2012 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests.
For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antib Terminated |
GQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.