The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Anti-dsdna.
Device ID | K925783 |
510k Number | K925783 |
Device Name: | AUTOSTAT ANTI-DSDNA |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep, GB |
Contact | Peter Mcgregor |
Correspondent | Peter Mcgregor COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep, GB |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-02 |
Decision Date | 1993-03-22 |