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FDA 510(k) Application Details - K042379
Device Classification Name
Whole Blood Hemoglobin Determination
More FDA Info for this Device
510(K) Number
K042379
Device Name
Whole Blood Hemoglobin Determination
Applicant
BIOSAFE LABORATORIES, INC.
100 FIELD DRIVE #240
LAKE FOREST, IL 60045 US
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Contact
JACK A MAGGIORE
Other 510(k) Applications for this Contact
Regulation Number
864.7500
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Classification Product Code
KHG
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More FDA Info for this Product Code
Date Received
09/01/2004
Decision Date
12/15/2004
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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