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 Nadh Oxidation/Nad Reduction, Ast/Sgot
510(k) Number K851267
Device Name GEMENI AST-LTS REAGENTS
Applicant
Electro-Nucleonics Laboratories, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Applicant Contact LA BREC
Correspondent
Electro-Nucleonics Laboratories, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Correspondent Contact LA BREC
Regulation Number862.1100
Classification Product Code
CIT  
Date Received03/29/1985
Decision Date 04/29/1985
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
-
-