The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Ck Reagent Cartridge (product No. 88213).
| Device ID | K861879 |
| 510k Number | K861879 |
| Device Name: | CK REAGENT CARTRIDGE (PRODUCT NO. 88213) |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea, CA 92621 |
| Contact | Andrew J Estrada |
| Correspondent | Andrew J Estrada HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea, CA 92621 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-15 |
| Decision Date | 1986-05-29 |