The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Poly-chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, And Total Protein Tests.
| Device ID | K110818 |
| 510k Number | K110818 |
| Device Name: | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS |
| Classification | Bromcresol Green Dye-binding, Albumin |
| 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 | CIX |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CIC |
| Subsequent Product Code | KHS |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-24 |
| Decision Date | 2011-09-08 |