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 K920751
Device Name SYVA EMIT II METHADONE ASSAY
Applicant
Syva Co.
P.O. Box 49013
San Jose,  CA  95161 -9013
Applicant Contact ROGERS, JR.
Correspondent
Syva Co.
P.O. Box 49013
San Jose,  CA  95161 -9013
Correspondent Contact ROGERS, JR.
Regulation Number862.3620
Classification Product Code
DJR  
Date Received02/19/1992
Decision Date 03/13/1992
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
-
-