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FDA 510(k) Application Details - K223038
Device Classification Name
Radioimmunoassay, Cortisol
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510(K) Number
K223038
Device Name
Radioimmunoassay, Cortisol
Applicant
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska, MN 55318 US
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Contact
Kuljeet Kaur
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Regulation Number
862.1205
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Classification Product Code
CGR
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More FDA Info for this Product Code
Date Received
09/29/2022
Decision Date
02/08/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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