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FDA 510(k) Application Details - K994100
Device Classification Name
Test, Time, Prothrombin
More FDA Info for this Device
510(K) Number
K994100
Device Name
Test, Time, Prothrombin
Applicant
PACIFIC HEMOSTASIS
11515 VANSTORY DR.
HUNTERSVILLE, NC 28078-8144 US
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Contact
LAURA A WORFOLK
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
12/03/1999
Decision Date
02/18/2000
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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