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FDA 510(k) Application Details - K994006
Device Classification Name
Test, Time, Prothrombin
More FDA Info for this Device
510(K) Number
K994006
Device Name
Test, Time, Prothrombin
Applicant
AVOCET MEDICAL, INC.
100 GREAT OAKS BLVD.
SAN JOSE, CA 95119 US
Other 510(k) Applications for this Company
Contact
JILL FALCONE
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
11/24/1999
Decision Date
02/03/2000
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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