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FDA 510(k) Application Details - K963111
Device Classification Name
Test, Time, Partial Thromboplastin
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510(K) Number
K963111
Device Name
Test, Time, Partial Thromboplastin
Applicant
CHROMOGENIX AB
P.O. BOX 262069
SAN DIEGO, CA 92196-2069 US
Other 510(k) Applications for this Company
Contact
RONALD G LEONARDI
Other 510(k) Applications for this Contact
Regulation Number
864.7925
More FDA Info for this Regulation Number
Classification Product Code
GGW
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More FDA Info for this Product Code
Date Received
08/12/1996
Decision Date
12/23/1996
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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