The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Thc Reagent, Calibrator Kit 30, Fs Calibrator 1, And Dat Performance Verifiers I, Ii, Iii, Iv.
| Device ID | K063164 |
| 510k Number | K063164 |
| Device Name: | VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| Subsequent Product Code | DLJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-18 |
| Decision Date | 2006-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750002832 | K063164 | 000 |
| 10758750001552 | K063164 | 000 |
| 10758750001804 | K063164 | 000 |