The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Direct Ldl Cholesterol Liquid Color And Stanbio Direct Hdl/ldl Cholesterol Calibrator.
Device ID | K032936 |
510k Number | K032936 |
Device Name: | DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR |
Classification | Calibrator, Multi-analyte Mixture |
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 | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-22 |
Decision Date | 2004-03-12 |
Summary: | summary |