MICT TSH


Device Classification Name

radioimmunoassay, thyroid-stimulating hormone

510(k) Number K110761
Device Name MICT TSH
Applicant
MAGNABIOSCIENCES, LLC
6325 lusk blvd
san diego, 
CA 
92121

Applicant Contact james l wyatt
Correspondent
MAGNABIOSCIENCES, LLC
6325 lusk blvd
san diego, 
CA 
92121

Correspodent Contact james l wyatt
Regulation Number 862.1690
Classification Product Code
JLW  
Subsequent Product Code
JJQ  
Date Received 03/18/2011
Decision Date 03/09/2012
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