CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K022725
Device Name CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013
Original Applicant
GOOD BIOTECH CORP.
38, 34th rd.
taichung industrial park
taichung, 

TW

407

Original Contact victor chiou
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 08/16/2002
Decision Date 09/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No