The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat(tm) Anti-dsna.
Device ID | K913342 |
510k Number | K913342 |
Device Name: | AUTOSTAT(TM) ANTI-DSNA |
Classification | Antinuclear Antibody, Antigen, Control |
Applicant | COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep, GB |
Contact | Mcgregor |
Correspondent | Mcgregor COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep, GB |
Product Code | LKJ |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-26 |
Decision Date | 1992-05-01 |