510(k) K002011 ยท MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
GLUTARTEST 1 REAGENT STRIP
| Applicant | Integrated Biomedical Technology, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Jan 22, 2001 |
| Received | Jul 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002011
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.