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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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
Correspondent Contact judith k ogden
Regulation Number862.1025
Classification Product Code
CKG  
Subsequent Product Codes
JIT   JJX  
Date Received05/12/2011
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
Recalls CDRH Recalls
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