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, Amphetamine
510(k) Number K934693
Device Name AMPHETAMINE TEST SYSTEM
Applicant
U.S. Drug Testing, Inc.
10410 Trademark St.
Rancho Cucamonga,  CA  91730
Applicant Contact CLIFFORD BENNETT
Correspondent
U.S. Drug Testing, Inc.
10410 Trademark St.
Rancho Cucamonga,  CA  91730
Correspondent Contact CLIFFORD BENNETT
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received09/30/1993
Decision Date 11/22/1993
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
-
-