CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET


Device Classification Name

system, test, c-reactive protein

510(k) Number K021757
Device Name CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
Original Applicant
GOOD BIOTECH CORP.
38, 34th rd.
taichung industrial park
taichung, 

TW

407

Original Contact victor chiou
Regulation Number 866.5270
Classification Product Code
DCN  
Date Received 05/29/2002
Decision Date 07/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No