The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Isocontrol Serum Ck-mb.
| Device ID | K850213 |
| 510k Number | K850213 |
| Device Name: | ISOCONTROL SERUM CK-MB |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | Debra Hofmeister |
| Correspondent | Debra Hofmeister SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-15 |
| Decision Date | 1985-03-05 |