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FDA 510(k) Application Details - K960557
Device Classification Name
Mixture, Hematology Quality Control
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510(K) Number
K960557
Device Name
Mixture, Hematology Quality Control
Applicant
STRECK LABORATORIES, INC.
14306 INDUSTRIAL RD.
OMAHA, NE 68144 US
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Contact
THEODORE W HEISE
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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
02/09/1996
Decision Date
04/03/1996
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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