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FDA 510(k) Application Details - K982245
Device Classification Name
Giardia Spp.
More FDA Info for this Device
510(K) Number
K982245
Device Name
Giardia Spp.
Applicant
BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO, CA 92121 US
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Contact
JOHN F BRUNI
Other 510(k) Applications for this Contact
Regulation Number
866.3220
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Classification Product Code
MHI
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More FDA Info for this Product Code
Date Received
06/26/1998
Decision Date
10/06/1998
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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