510(k) K090854 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090
| Applicant | American Biological Technologies, Inc., Seguin TX, US |
| Decision | Substantially Equivalent, Apr 16, 2009 |
| Received | Mar 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090854
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.