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 |