AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K050186
Device Name AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III
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

Correspodent Contact john wu
Regulation Number 862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   LCM   LDJ   LFG  
Date Received 01/27/2005
Decision Date 03/04/2005
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