The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Modified Intended Use Of Cleaning Reagent Kit.
| Device ID | K890184 |
| 510k Number | K890184 |
| Device Name: | MODIFIED INTENDED USE OF CLEANING REAGENT KIT |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| 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 | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-18 |
| Decision Date | 1989-02-07 |