The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Hi-chem Diagnostics Enzyme Rinse Concentrate.
| Device ID | K852867 |
| 510k Number | K852867 |
| Device Name: | HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| 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 | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-08 |
| Decision Date | 1985-08-29 |