The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Cpk(ck) In Vitro Diag. Reagent Set.
| Device ID | K813406 |
| 510k Number | K813406 |
| Device Name: | CPK(CK) IN VITRO DIAG. REAGENT SET |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | POINTE SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-07 |
| Decision Date | 1981-12-22 |