The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, Fs Calibrator 1 And Dat Performance Verifiers I, Ii, Iii, Iv.
| Device ID | K062123 |
| 510k Number | K062123 |
| Device Name: | VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Michael M Byrne |
| Correspondent | Michael M Byrne Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | DIO |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-25 |
| Decision Date | 2006-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750002658 | K062123 | 000 |
| 10758750002641 | K062123 | 000 |
| 10758750002634 | K062123 | 000 |
| 10758750002627 | K062123 | 000 |
| 10758750002610 | K062123 | 000 |