The following data is part of a premarket notification filed by Diagnostic Systems with the FDA for Hdl Precipitating Reagent.
| Device ID | K893966 |
| 510k Number | K893966 |
| Device Name: | HDL PRECIPITATING REAGENT |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna G Bentley |
| Correspondent | Anna G Bentley DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-02 |
| Decision Date | 1989-07-25 |