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 Enzyme Immunoassay, Benzodiazepine
510(k) Number K863877
Device Name BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
Applicant
General Diagnostics
160 Community Dr.
Great Neck,  NY  11021
Applicant Contact AKERKAR, PH.D.
Correspondent
General Diagnostics
160 Community Dr.
Great Neck,  NY  11021
Correspondent Contact AKERKAR, PH.D.
Regulation Number862.3170
Classification Product Code
JXM  
Date Received10/06/1986
Decision Date 03/12/1987
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
-
-