The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for New Enzymatic Single Reagent Free Chol..
| Device ID | K822417 |
| 510k Number | K822417 |
| Device Name: | NEW ENZYMATIC SINGLE REAGENT FREE CHOL. |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | SCLAVO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-11 |
| Decision Date | 1982-10-21 |