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, Androstenedione
510(k) Number K860559
Device Name ANDROSTENEDIONE 125I KIT BY RIA
Applicant
Immuchem Corp.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Applicant Contact BURNS, PHD
Correspondent
Immuchem Corp.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Correspondent Contact BURNS, PHD
Regulation Number862.1075
Classification Product Code
CIZ  
Date Received02/14/1986
Decision Date 03/14/1986
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
-
-