The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Tsh Control.
| Device ID | K915325 |
| 510k Number | K915325 |
| Device Name: | TSH CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | Frank J Coviello |
| Correspondent | Frank J Coviello POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-22 |
| Decision Date | 1992-03-02 |