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FDA 510(k) Application Details - K221990
Device Classification Name
System, Test, Human Chorionic Gonadotropin
More FDA Info for this Device
510(K) Number
K221990
Device Name
System, Test, Human Chorionic Gonadotropin
Applicant
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska, MN 55318 US
Other 510(k) Applications for this Company
Contact
Kate Oelberg
Other 510(k) Applications for this Contact
Regulation Number
862.1155
More FDA Info for this Regulation Number
Classification Product Code
DHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/06/2022
Decision Date
12/27/2022
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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