510(k) K142595 ยท PDJ Hemoglobin A1c Test System
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
| Applicant | Ortho Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Jun 4, 2015 |
| Received | Sep 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142595
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood.
Product Code Open, Classified |
PDJ | None listed |
| Apr 19, 2016 | Ortho-Clinical Diagnostics The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions ( Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.