MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23


Device Classification Name

enzyme immunoassay, opiates

510(k) Number K030113
Device Name MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23
Original Applicant
BRANAN MEDICAL CORP.
10015 muirlands rd., suite e
irvine, 
CA 
92618

Original Contact raphael wong
Regulation Number 862.3650
Classification Product Code
DJG  
Date Received 01/13/2003
Decision Date 07/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No