The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Quantaffirm Cpk Iso Enzyme Serum (human).
| Device ID | K791723 |
| 510k Number | K791723 |
| Device Name: | QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | ORGANON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-30 |
| Decision Date | 1979-10-01 |