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FDA 510(k) Application Details - K030964
Device Classification Name
Calibrator, Primary
More FDA Info for this Device
510(K) Number
K030964
Device Name
Calibrator, Primary
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD, MA 01730 US
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Contact
CAROL MARBLE
Other 510(k) Applications for this Contact
Regulation Number
862.1150
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Classification Product Code
JIS
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More FDA Info for this Product Code
Date Received
03/27/2003
Decision Date
06/06/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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