The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic Products Range Verifiers.
| Device ID | K973517 |
| 510k Number | K973517 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Contact | Ann M Quinn |
| Correspondent | Ann M Quinn JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-17 |
| Decision Date | 1997-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750000777 | K973517 | 000 |
| 10758750000760 | K973517 | 000 |
| 10758750000753 | K973517 | 000 |
| 10758750000784 | K973517 | 000 |
| 10758750000746 | K973517 | 000 |
| 10758750000739 | K973517 | 000 |
| 10758750000715 | K973517 | 000 |
| 10758750000708 | K973517 | 000 |
| 10758750000692 | K973517 | 000 |