CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD


Device Classification Name

enzyme immunoassay, benzodiazipine

510(k) Number K111322
Device Name CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD
Applicant
CHEMTRON BIOTECH, INC.
8370 juniper creek lane
suite 1-2
san diego, 
CA 
92126

Applicant Contact jane zhang
Correspondent
CHEMTRON BIOTECH, INC.
8370 juniper creek lane
suite 1-2
san diego, 
CA 
92126

Correspodent Contact jane zhang
Regulation Number 862.3170
Classification Product Code
JXM  
Subsequent Product Codes
DIS   DJC   DJG   DJR  
Date Received 05/11/2011
Decision Date 09/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No