510(k) K052645 ยท GTQ Antistreptolysin - Titer/Streptolysin O Reagent
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Dec 14, 2005 |
| Received | Sep 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052645
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.