CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510


Device Classification Name

system, test, c-reactive protein

510(k) Number K021882
Device Name CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
Original Applicant
GOOD BIOTECH CORP.
38, 34th rd.
taichung industrial park
taichung city, 

CN

Original Contact victor chiou
Regulation Number 866.5270
Classification Product Code
DCN  
Date Received 06/07/2002
Decision Date 07/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No