The following data is part of a premarket notification filed by Carolina Liquid Chemistries Corp. with the FDA for Ck Reagent.
| Device ID | K971396 |
| 510k Number | K971396 |
| Device Name: | CK REAGENT |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | CAROLINA LIQUID CHEMISTRIES CORP. 451 WEST LAMBERT RD., SUITE 207 Brea, CA 92821 |
| Contact | Cynthia Shugart |
| Correspondent | Cynthia Shugart CAROLINA LIQUID CHEMISTRIES CORP. 451 WEST LAMBERT RD., SUITE 207 Brea, CA 92821 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-15 |
| Decision Date | 1997-05-29 |