510(k) K100602 ยท KHP Acid, Lactic, Enzymatic Method
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, Aug 17, 2011 |
| Received | Mar 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100602
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.