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 |