The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Triglycerides Reagent (product #88218).
| Device ID | K883405 |
| 510k Number | K883405 |
| Device Name: | TRIGLYCERIDES REAGENT (PRODUCT #88218) |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| 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 | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-11 |
| Decision Date | 1988-09-13 |