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FDA 510(k) Application Details - K955638
Device Classification Name
Activated Partial Thromboplastin
More FDA Info for this Device
510(K) Number
K955638
Device Name
Activated Partial Thromboplastin
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
RARITAN, NJ 08869-0606 US
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Contact
BLANCHE CHIEN
Other 510(k) Applications for this Contact
Regulation Number
864.7925
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Classification Product Code
GFO
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More FDA Info for this Product Code
Date Received
12/11/1995
Decision Date
04/23/1996
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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