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 Fluorescence Polarization Immunoassay, Phenobarbital
510(k) Number K862528
Device Name IMMPULSE PHENOBARBITAL 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 Number862.3660
Classification Product Code
LGQ  
Date Received07/02/1986
Decision Date 07/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-