510(k) K922826 ยท FGA Kit, Nephroscope
FLEXIBLE FIBER OPTIC ENDOSCOPE
| Applicant | Optimed Technologies, Inc., Orange CA, US |
| Decision | Substantially Equivalent, Feb 19, 1993 |
| Received | Jun 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922826
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2011 | Beckman Coulter Inc. Access Immunoassay Systems, Part Number 81600N & 81600N.
An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found i Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.