510(k) K023561 ยท GKR System, Hemoglobin, Automated
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Jan 31, 2003 |
| Received | Oct 23, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023561
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.