The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Op Reagent, Calibrator Kit 26 And Dat Performance Verifiers I, Ii And Iii.
| Device ID | K062460 |
| 510k Number | K062460 |
| Device Name: | VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Marlene A Hanna |
| Correspondent | Marlene A Hanna Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | DJG |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-23 |
| Decision Date | 2006-12-15 |
| Summary: | summary |