510(k) K011478 ยท KHP Acid, Lactic, Enzymatic Method
I-STAT SYSTEM
| Applicant | I-Stat Corp., East Windsor NJ, US |
| Decision | Substantially Equivalent, Jul 2, 2001 |
| Received | May 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011478
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.