The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Cobas Standards For Calcium-in-organic.
| Device ID | K823578 |
| 510k Number | K823578 |
| Device Name: | COBAS STANDARDS FOR CALCIUM-IN-ORGANIC |
| Classification | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | HOFFMANN-LA ROCHE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIO |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-06 |
| Decision Date | 1983-01-07 |