The following data is part of a premarket notification filed by American Dade with the FDA for Paramax Cholesterol Reagent.
| Device ID | K872050 |
| 510k Number | K872050 |
| Device Name: | PARAMAX CHOLESTEROL REAGENT |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Krista Underwood |
| Correspondent | Krista Underwood AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-28 |
| Decision Date | 1987-07-07 |