The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Hdl Cholesterol Reagent; Olympus Hdl Cholesterol Calibrator; Olympus Hdl/ldl Cholesterol Control Sera.
| Device ID | K014015 |
| 510k Number | K014015 |
| Device Name: | OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Contact | Michael Campbell |
| Correspondent | Michael Campbell OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Product Code | LBS |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-05 |
| Decision Date | 2002-02-08 |