The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; Fs Calibrator 1; Dat Performance Verifiers.
| Device ID | K062077 |
| 510k Number | K062077 |
| Device Name: | VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DLJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-21 |
| Decision Date | 2006-11-22 |
| Summary: | summary |