The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Hcg Control.
| Device ID | K921206 |
| 510k Number | K921206 |
| Device Name: | HCG 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 | 1992-03-13 |
| Decision Date | 1992-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817439020857 | K921206 | 000 |
| 00817439020840 | K921206 | 000 |
| 00817439020833 | K921206 | 000 |
| 00817439020826 | K921206 | 000 |
| 00817439020819 | K921206 | 000 |
| 00855574005391 | K921206 | 000 |
| 00855574005377 | K921206 | 000 |