BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D


codes

Device Classification Name

enzyme immunoassay, methadone

510(k) Number K002417
Device Name BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D
Original Applicant
BRANAN MEDICAL CORPORATION
10015 muirlands rd. suite e
irvine, 
CA 
92618

Original Contact raphael wong
Regulation Number 862.3620
Classification Product Code
DJR  
Date Received 08/08/2000
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