The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Hdl-cholesterol Control Serum.
| Device ID | K802997 |
| 510k Number | K802997 |
| Device Name: | HDL-CHOLESTEROL CONTROL SERUM |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ISOLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-25 |
| Decision Date | 1980-12-22 |