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, testosterones and dihydrotestosterone
510(k) Number K915570
Device Name GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT
Applicant
INCSTAR CORP.
1990 INSUSTRIAL BLVD.
P.O. BOX 285
STILLWATER,  MN  55082 -0285
Applicant Contact ELLEN BEST
Correspondent
INCSTAR CORP.
1990 INSUSTRIAL BLVD.
P.O. BOX 285
STILLWATER,  MN  55082 -0285
Correspondent Contact ELLEN BEST
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received12/12/1991
Decision Date 01/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-