The following data is part of a premarket notification filed by Elan Diagnostics with the FDA for Atac Direct Hdl Cholesterol Reagent And Atac Hdl-c Calibrator Kits.
| Device ID | K992029 |
| 510k Number | K992029 |
| Device Name: | ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | ELAN DIAGNOSTICS 231 NORTH PUENTE ST. Brea, CA 92821 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking ELAN DIAGNOSTICS 231 NORTH PUENTE ST. Brea, CA 92821 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-16 |
| Decision Date | 1999-08-12 |
| Summary: | summary |