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FDA 510(k) Application Details - K992851
Device Classification Name
Activated Whole Blood Clotting Time
More FDA Info for this Device
510(K) Number
K992851
Device Name
Activated Whole Blood Clotting Time
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS, IN 46250-0457 US
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Contact
LUANN OCHS
Other 510(k) Applications for this Contact
Regulation Number
864.7140
More FDA Info for this Regulation Number
Classification Product Code
JBP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/24/1999
Decision Date
01/14/2000
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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