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FDA 510(k) Application Details - K220085
Device Classification Name
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
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510(K) Number
K220085
Device Name
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
Applicant
KRONUS, Inc.
170 S. Seneca Springs Way
Suite 105
Star, ID 83669 US
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Contact
Delaney Sauer
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Regulation Number
866.5660
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Classification Product Code
OIF
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Date Received
01/11/2022
Decision Date
08/24/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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