GBI TSH NEONATAL SCREENING KIT


Device Classification Name

radioimmunoassay, thyroid-stimulating hormone

510(k) Number K072458
Device Name GBI TSH NEONATAL SCREENING KIT
Applicant
GOLDEN BRIDGE INTERNATIONAL, INC.
9700 harbour pl. suite 129
mukilteo, 
WA 
98275

Applicant Contact xiaoping zhang
Correspondent
GOLDEN BRIDGE INTERNATIONAL, INC.
9700 harbour pl. suite 129
mukilteo, 
WA 
98275

Correspodent Contact xiaoping zhang
Regulation Number 862.1690
Classification Product Code
JLW  
Date Received 08/31/2007
Decision Date 04/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No