510(k) K854025 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
HITACHI 704
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 28, 1985 |
| Received | Sep 30, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854025
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2006 | Roche Diagnostics Corp. Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic. Terminated |
CFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.