The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Ck-nac Reagent.
| Device ID | K974833 |
| 510k Number | K974833 |
| Device Name: | CK-NAC REAGENT |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | INTERSECT SYSTEMS, INC. P.O. BOX 2219 Longview, WA 98632 |
| Contact | Mark E Legaz |
| Correspondent | Mark E Legaz INTERSECT SYSTEMS, INC. P.O. BOX 2219 Longview, WA 98632 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-24 |
| Decision Date | 1998-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851445007143 | K974833 | 000 |
| 00851445007136 | K974833 | 000 |