UCP HOME DRUG SCREENING TEST CUPS


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K122419
Device Name UCP HOME DRUG SCREENING TEST CUPS
Applicant
UCP BIOSCIENCES, INC.
1445 koll circle, ste. 111
san jose, 
CA 
95112

Applicant Contact nancy chen
Correspondent
UCP BIOSCIENCES, INC.
1445 koll circle, ste. 111
san jose, 
CA 
95112

Correspodent Contact nancy chen
Regulation Number 862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   LCM   LDJ   LFG  
Date Received 08/09/2012
Decision Date 11/30/2012
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