The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Amresco Flow Pac Creatine Phosphokinase Reagent.
| Device ID | K860663 |
| 510k Number | K860663 |
| Device Name: | AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Contact | Timothy J Belcastro |
| Correspondent | Timothy J Belcastro AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-24 |
| Decision Date | 1986-04-11 |