The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Poly-chem 90 Direct Hdl Cholesterol, Poly-chem 90 Direct Ldl Cholesterol, Poly-chem 90 Cholesterol, Poly-chem 90 Triglyc.
| Device ID | K100550 |
| 510k Number | K100550 |
| Device Name: | POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | Helen Landicho |
| Correspondent | Helen Landicho POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | LBS |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CHH |
| Subsequent Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-26 |
| Decision Date | 2010-09-28 |
| Summary: | summary |