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FDA 510(k) Application Details - K030320
Device Classification Name
Calibrator, Primary
More FDA Info for this Device
510(K) Number
K030320
Device Name
Calibrator, Primary
Applicant
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND, VA 23237 US
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Contact
LORI CREASY
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
01/30/2003
Decision Date
04/11/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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