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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Barbiturate
510(k) Number K042975
Device Name AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II
Applicant
AMEDITECH, INC.
10340 CAMINO SANTA FE
SUITES F-G
SAN DIEGO,  CA  92121
Applicant Contact JOHN WU
Correspondent
AMEDITECH, INC.
10340 CAMINO SANTA FE
SUITES F-G
SAN DIEGO,  CA  92121
Correspondent Contact JOHN WU
Regulation Number862.3150
Classification Product Code
DIS  
Subsequent Product Codes
DJG   DJR   JXM   LAF  
Date Received10/28/2004
Decision Date 12/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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