UCP DRUG SCREENING TEST CUPS


Device Classification Name

enzyme immunoassay, barbiturate

510(k) Number K110515
Device Name UCP 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 862.3150
Classification Product Code
DIS  
Subsequent Product Codes
DIO   DJC   DJG   DJR   JXM  
LCM   LDJ   LFG  
Date Received 02/23/2011
Decision Date 04/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No