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 |