The following data is part of a premarket notification filed by Synergent Biochem Inc.-clinical Controls Div. with the FDA for Liquispx Hdl/ldl Liquid Cholesterol Calibrator.
| Device ID | K010030 |
| 510k Number | K010030 |
| Device Name: | LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SYNERGENT BIOCHEM INC.-CLINICAL CONTROLS DIV. 12038 CENTRAILIA AVE. SUITE C Hawaiian Gardens, CA 90716 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey SYNERGENT BIOCHEM INC.-CLINICAL CONTROLS DIV. 12038 CENTRAILIA AVE. SUITE C Hawaiian Gardens, CA 90716 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-03 |
| Decision Date | 2001-02-14 |