510(k) K946224 ยท JJS Controls For Blood-Gases, (Assayed And Unassayed)
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
| Applicant | Ciba Corning Diagnostics Corp., East Walpole MA, US |
| Decision | Substantially Equivalent, Jan 30, 1995 |
| Received | Nov 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946224
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.