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 Radioimmunoassay, Acth
510(k) Number K860311
Device Name ACTHK-PR RIA KIT
Applicant
Compagnie Oris Industrie, S.A.
C/O Cis-Us, Inc.
1983 Marcus Ave.
Lake Success,  NY  11042
Applicant Contact MICHAEL D GARRET
Correspondent
Compagnie Oris Industrie, S.A.
C/O Cis-Us, Inc.
1983 Marcus Ave.
Lake Success,  NY  11042
Correspondent Contact MICHAEL D GARRET
Regulation Number862.1025
Classification Product Code
CKG  
Date Received01/28/1986
Decision Date 04/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-