BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D


codes

Device Classification Name

enzyme immunoassay, phencyclidine

510(k) Number K002272
Device Name BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D
Original Applicant
BRANAN MEDICAL CORP.
10015 muirlands rd., suite e
irvine, 
CA 
92618

Original Contact raphael wong
Regulation Number 862.3100
Classification Product Code
LCM  
Date Received 07/26/2000
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