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FDA 510(k) Application Details - K220282
Device Classification Name
Test, Time, Prothrombin
More FDA Info for this Device
510(K) Number
K220282
Device Name
Test, Time, Prothrombin
Applicant
Abbott Laboratories
400 College Road East
Princeton, NJ 08540 US
Other 510(k) Applications for this Company
Contact
Melissa Tristani
Other 510(k) Applications for this Contact
Regulation Number
864.7750
More FDA Info for this Regulation Number
Classification Product Code
GJS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2022
Decision Date
07/14/2023
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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