510(k) K090943 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
| Applicant | American Biological Technologies, Inc., Seguin TX, US |
| Decision | Substantially Equivalent, May 27, 2009 |
| Received | Apr 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090943
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.