Atlas FDA

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

FDA 510(k) clearance K111335 · decided 2011-12-01

Clearance details

K-number
K111335
Device name
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
Applicant
Tosoh Bioscience, Inc.
Decision
Substantially Equivalent
Date received
2011-05-12
Decision date
2011-12-01
Days to decision
203 days
Clearance type
Traditional
Product code
CKG
Device class
2
Regulation number
862.1025
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
South San Franciso, CA, US
Third-party review
No
Expedited review
No

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IMMULITE ACTH (K960066)Diagnostic Products Corp.1996-02-16
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
AIA-PACK PSA (P910065/S009)Tosoh Bioscience, Inc.2019-06-18
IMMUNOASAY, PSA (P910065/S008)Tosoh Bioscience, Inc.2012-02-13
ST AIA-PACK PA (P910065/S007)Tosoh Bioscience, Inc.2009-11-30
AIA-PACK PA PSA, ST AIA-PACK PA PSA (P910065/S006)Tosoh Bioscience, Inc.2005-11-30
ST AIA-PACK PA (P910065/S005)Tosoh Bioscience, Inc.2004-05-25
ST AIA-PACK PA (P910065/S004)Tosoh Bioscience, Inc.2003-08-12
AIA-PACK PA (P910065/S003)Tosoh Bioscience, Inc.2002-09-09
AIA PACK PA (P910065/S002)Tosoh Bioscience, Inc.2000-03-03