The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Direct Hdl-cholesterol Liquid Color; Direct Hdl/ldl-cholesterol Calibrator.
| Device ID | K032932 |
| 510k Number | K032932 |
| Device Name: | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne, TX 78006 |
| Contact | Adaobi Oguchi |
| Correspondent | Adaobi Oguchi STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne, TX 78006 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2004-03-10 |
| Summary: | summary |