The following data is part of a premarket notification filed by Preventive Diagnostics Corp. with the FDA for Hdl Cholesterol Aqueous Standards.
| Device ID | K840220 |
| 510k Number | K840220 |
| Device Name: | HDL CHOLESTEROL AQUEOUS STANDARDS |
| Classification | Calibrator, Primary |
| Applicant | PREVENTIVE DIAGNOSTICS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-19 |
| Decision Date | 1984-03-23 |