The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Cancer Antigen Control.
| Device ID | K924061 |
| 510k Number | K924061 |
| Device Name: | CANCER ANTIGEN CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-12 |
| Decision Date | 1993-02-23 |