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FDA 510(k) Application Details - K221508
Device Classification Name
Whole Blood Hemoglobin Determination
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510(K) Number
K221508
Device Name
Whole Blood Hemoglobin Determination
Applicant
Sanguina, Inc.
147 Technology Parkway Ste 100
Peachtree Corners, GA 30092 US
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Contact
Cathryn Cambria
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Regulation Number
864.7500
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Classification Product Code
KHG
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More FDA Info for this Product Code
Date Received
05/24/2022
Decision Date
09/29/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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