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FDA 510(k) Application Details - K011410
Device Classification Name
Mixture, Hematology Quality Control
More FDA Info for this Device
510(K) Number
K011410
Device Name
Mixture, Hematology Quality Control
Applicant
STRECK LABORATORIES, INC.
7002 SOUTH 109TH ST.
LA VISTA, NE 68128 US
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Contact
PAUL KETTELSON
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Regulation Number
864.8625
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Classification Product Code
JPK
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More FDA Info for this Product Code
Date Received
05/08/2001
Decision Date
06/26/2001
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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