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FDA 510(k) Application Details - K063295
Device Classification Name
Test, Urine Leukocyte
More FDA Info for this Device
510(K) Number
K063295
Device Name
Test, Urine Leukocyte
Applicant
ACON LABORATORIES, INC.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO, CA 92121 US
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Contact
JINN-NAN LIN
Other 510(k) Applications for this Contact
Regulation Number
864.7675
More FDA Info for this Regulation Number
Classification Product Code
LJX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/01/2006
Decision Date
10/12/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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