The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hi Chem Creatinine Reagent (product #88809).
| Device ID | K890671 |
| 510k Number | K890671 |
| Device Name: | HI CHEM CREATININE REAGENT (PRODUCT #88809) |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Contact | Bentley Tam |
| Correspondent | Bentley Tam HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-09 |
| Decision Date | 1989-05-09 |