The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Cholesterol Reagents, Prod. # 7325.
| Device ID | K891922 |
| 510k Number | K891922 |
| Device Name: | AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | C. K Owens |
| Correspondent | C. K Owens AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-27 |
| Decision Date | 1989-06-16 |