The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Hdl Cholesterol Reag. System.
| Device ID | K792319 |
| 510k Number | K792319 |
| Device Name: | COULTER HDL CHOLESTEROL REAG. SYSTEM |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-19 |
| Decision Date | 1979-12-06 |