The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Poly-chem 90 Total Bilirubin.
| Device ID | K111143 |
| 510k Number | K111143 |
| Device Name: | POLY-CHEM 90 TOTAL BILIRUBIN |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-22 |
| Decision Date | 2011-09-01 |
| Summary: | summary |