The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Creatine Kinase Reagent Kit.
| Device ID | K930932 |
| 510k Number | K930932 |
| Device Name: | SYNERMED CREATINE KINASE REAGENT KIT |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, CA H8t 2v5 |
| Contact | Marcia J Artentz |
| Correspondent | Marcia J Artentz SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, CA H8t 2v5 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-23 |
| Decision Date | 1993-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091866 | K930932 | 000 |
| 05060500090722 | K930932 | 000 |
| 05060500090715 | K930932 | 000 |
| 05060500090708 | K930932 | 000 |
| 05060500090692 | K930932 | 000 |
| 05060500090685 | K930932 | 000 |
| 05060500090678 | K930932 | 000 |
| 05060500090661 | K930932 | 000 |