Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K925783
Device Name AUTOSTAT ANTI-DSDNA
Applicant
Cogent Diagnotics , Ltd.
Allanwater Business Centre
Stirling Rd.
Dunblane, Fk15 9ep,  GB
Applicant Contact PETER MCGREGOR
Correspondent
Cogent Diagnotics , Ltd.
Allanwater Business Centre
Stirling Rd.
Dunblane, Fk15 9ep,  GB
Correspondent Contact PETER MCGREGOR
Regulation Number862.1660
Classification Product Code
JJX  
Date Received11/02/1992
Decision Date 03/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-