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FDA 510(k) Application Details - K981651
Device Classification Name
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510(K) Number
K981651
Device Name
AB FLU OIA
Applicant
BIOSTAR, INC.
6655 LOOKOUT RD.
BOULDER, CO 80301 US
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Contact
ROGER C BRIDEN
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Regulation Number
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Classification Product Code
PSZ
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Date Received
05/11/1998
Decision Date
11/25/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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