The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Human Plasma Control For Cea-roche.
| Device ID | K822219 |
| 510k Number | K822219 |
| Device Name: | HUMAN PLASMA CONTROL FOR CEA-ROCHE |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | HOFFMANN-LA ROCHE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-26 |
| Decision Date | 1982-12-28 |