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, Barbiturate
510(k) Number K931535
Device Name EMIT(R) D.A.U. BARBITURATE ASSAY
Applicant
Syva Co.
P.O. Box 49013
San Jose,  CA  95161
Applicant Contact PAUL L ROGERS
Correspondent
Syva Co.
P.O. Box 49013
San Jose,  CA  95161
Correspondent Contact PAUL L ROGERS
Regulation Number862.3150
Classification Product Code
DIS  
Date Received03/29/1993
Decision Date 06/15/1993
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
-
-