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FDA 510(k) Application Details - K050352
Device Classification Name
Discs, Strips And Reagents, Microorganism Differentiation
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510(K) Number
K050352
Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Applicant
AMERITEK RESEARCH LLC
15205 3RD DR. SE
MILL CREEK, WA 98012 US
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Contact
KUD CHAIANG YEE
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Regulation Number
866.2660
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Classification Product Code
JTO
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Date Received
02/11/2005
Decision Date
09/01/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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