The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hi Chem Kinetic Cholesterol Reagent #88218.
| Device ID | K883844 |
| 510k Number | K883844 |
| Device Name: | HI CHEM KINETIC CHOLESTEROL REAGENT #88218 |
| 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 | 1988-09-12 |
| Decision Date | 1988-10-31 |