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FDA 510(k) Applications Submitted by JUDITH K OGDEN
FDA 510(k) Number
Submission Date
Device Name
Applicant
K100304
02/03/2010
ST AIA PACK HBA1C
Tosoh BioScience, Inc.
K111335
05/12/2011
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
Tosoh BioScience, Inc.
K111762
06/23/2011
ST AIA-PACK DHEA-S CALIBRATOR SET
Tosoh BioScience, Inc.
K093960
12/23/2009
ST AIA-PACK CYSTATIN C, MODEL 025217
Tosoh BioScience, Inc.
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