The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Cobas Standard For Total Protein.
Device ID | K823576 |
510k Number | K823576 |
Device Name: | COBAS STANDARD FOR TOTAL PROTEIN |
Classification | Fluorescent Immunoassay, Theophylline |
Applicant | HOFFMANN-LA ROCHE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LER |
CFR Regulation Number | 862.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-06 |
Decision Date | 1983-01-07 |