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, Methadone
510(k) Number K920858
Device Name IL TEST METHADONE
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Applicant Contact GABRIEL J MURACA,JR
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Correspondent Contact GABRIEL J MURACA,JR
Regulation Number862.3620
Classification Product Code
DJR  
Date Received02/25/1992
Decision Date 04/24/1992
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
-
-