ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321


Device Classification Name

radioimmunoassay, acth

510(k) Number K111335
Device Name ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
Applicant
Tosoh BioScience, Inc.
6000 shoreline court
suite 101
south san francisco, 
CA 
94080

Applicant Contact judith k ogden
Correspondent
Tosoh BioScience, Inc.
6000 shoreline court
suite 101
south san francisco, 
CA 
94080

Correspodent Contact judith k ogden
Regulation Number 862.1025
Classification Product Code
CKG  
Subsequent Product Codes
JIT   JJX  
Date Received 05/12/2011
Decision Date 12/01/2011
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