The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Extend Intended Use For Enzyme Rinse Concentrate.
| Device ID | K890990 |
| 510k Number | K890990 |
| Device Name: | EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-27 |
| Decision Date | 1989-04-10 |