BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST


definition

Device Classification Name

enzyme immunoassay, benzodiazipine

510(k) Number K002342
Device Name BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
Original Applicant
BRANAN MEDICAL CORPORATION
10015 muirlands rd. suite e
irvine, 
CA 
92618

Original Contact raphael wong
Regulation Number 862.3170
Classification Product Code
JXM  
Date Received 08/01/2000
Decision Date 11/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No