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FDA 510(k) Application Details - K051088
Device Classification Name
Calibrators, Drug Mixture
More FDA Info for this Device
510(K) Number
K051088
Device Name
Calibrators, Drug Mixture
Applicant
Lin-Zhi International, Inc.
687 NORTH PASTORIA AVE.
SUNNYVALE, CA 94085-2917 US
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Contact
CHENG-I LIN
Other 510(k) Applications for this Contact
Regulation Number
862.3200
More FDA Info for this Regulation Number
Classification Product Code
DKB
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More FDA Info for this Product Code
Date Received
04/28/2005
Decision Date
06/24/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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