BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST


definition

Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K002266
Device Name BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST
Original Applicant
BRANAN MEDICAL CORPORATION
10015 muirlands rd. suite e
irvine, 
CA 
92618

Original Contact raphael wong
Regulation Number 862.3100
Classification Product Code
DKZ  
Date Received 07/25/2000
Decision Date 11/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No