The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Chemistry Products Hba 1c Reagent Kit, Vitros Calibrator Kit 31, Vitros Chemistry Products %a1c Performance Verifiers I And Ii.
| Device ID | K142595 |
| 510k Number | K142595 |
| Device Name: | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I And II |
| Classification | Hemoglobin A1c Test System |
| Applicant | ORTHO CLINICAL DIAGNOSTICS 100 INDIGO CREEK DRIVE Rochester, NY 14626 |
| Contact | Bradley P Boyer |
| Correspondent | Bradley P Boyer ORTHO CLINICAL DIAGNOSTICS 100 INDIGO CREEK DRIVE Rochester, NY 14626 |
| Product Code | PDJ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2015-06-04 |
| Summary: | summary |