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FDA 510(k) Application Details - K080812
Device Classification Name
Reagent, Occult Blood
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510(K) Number
K080812
Device Name
Reagent, Occult Blood
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
PO BOX 8000
BREA, CA 92822 US
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Contact
SYLVIA ZORICH
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Regulation Number
864.6550
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Classification Product Code
KHE
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More FDA Info for this Product Code
Date Received
03/24/2008
Decision Date
06/25/2008
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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