510(k) K013938 ยท KHP Acid, Lactic, Enzymatic Method
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
| Applicant | Diametrics Medical, Inc., Roseville MN, US |
| Decision | Substantially Equivalent, Jan 28, 2002 |
| Received | Nov 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013938
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.