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 |