The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Upro Slides.
| Device ID | K964960 |
| 510k Number | K964960 |
| Device Name: | VITROS CHEMISTRY PRODUCTS UPRO SLIDES |
| Classification | Lowry (colorimetric), Total Protein |
| Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Contact | Charles C Morganson, Jr. |
| Correspondent | Charles C Morganson, Jr. JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Product Code | JGP |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-11 |
| Decision Date | 1997-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750000630 | K964960 | 000 |
| 10758750000623 | K964960 | 000 |