• 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, total thyroxine
510(k) Number K875081
Device Name IMMPULSE T4 ASSAY REAGENTS
Applicant
SCLAVO, INC.
1240 ELKO DR.
SUNNYVALE,  CA  94089
Applicant Contact MICHAEL BRINKLEY
Correspondent
SCLAVO, INC.
1240 ELKO DR.
SUNNYVALE,  CA  94089
Correspondent Contact MICHAEL BRINKLEY
Regulation Number862.1700
Classification Product Code
CDX  
Date Received12/09/1987
Decision Date 02/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-