510(k) K103195 ยท CGA Glucose Oxidase, Glucose
I-STAT 1 WIRELESS ANALYZER
| Applicant | Abbott Point of Care, Inc., Princton NJ, US |
| Decision | Substantially Equivalent, Feb 8, 2011 |
| Received | Oct 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103195
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.