510(k) K864082 ยท CKD Hydrazone Colorimetry, Alt/Sgpt
REFLOTRON(R) ALT (GPT)
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 4, 1986 |
| Received | Oct 20, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2004 | Roche Diagnostics Corp. Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138. Terminated |
CIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.