The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; Fs Calibrator 1; Dat Performance Verifiers.
| Device ID | K062165 |
| 510k Number | K062165 |
| Device Name: | VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Marlene Hanna |
| Correspondent | Marlene Hanna ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | DIS |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-28 |
| Decision Date | 2007-01-05 |
| Summary: | summary |