The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Isoenzyme Test Ck-mb.
| Device ID | K850212 |
| 510k Number | K850212 |
| Device Name: | ISOENZYME TEST CK-MB |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| 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 | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-15 |
| Decision Date | 1985-02-07 |