The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Creatine Kinase (ck-nac).
| Device ID | K013912 |
| 510k Number | K013912 |
| Device Name: | CREATINE KINASE (CK-NAC) |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-27 |
| Decision Date | 2002-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274021354 | K013912 | 000 |
| 00817274021347 | K013912 | 000 |
| 00817274021330 | K013912 | 000 |
| 00817274021323 | K013912 | 000 |