510(k) K052010 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
HBA1C LINEARITY SET
| Applicant | Cone Bioproducts, Seguin TX, US |
| Decision | Substantially Equivalent, Oct 4, 2005 |
| Received | Jul 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052010
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.