The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Cholesterol Rapid Liquid Reagent.
| Device ID | K972853 |
| 510k Number | K972853 |
| Device Name: | CHOLESTEROL RAPID LIQUID REAGENT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | Daniel C Weyker |
| Correspondent | Daniel C Weyker REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-27 |
| Decision Date | 1997-09-24 |