510(k) K011953 ยท CGA Glucose Oxidase, Glucose
WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA
| Applicant | Wiener Laboratories Saic, Rosario, Santa Fe, AR |
| Decision | Substantially Equivalent, Dec 21, 2001 |
| Received | Jun 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011953
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.