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FDA 510(k) Application Details - K141775
Device Classification Name
Antigens, All Groups, Streptococcus Spp.
More FDA Info for this Device
510(K) Number
K141775
Device Name
Antigens, All Groups, Streptococcus Spp.
Applicant
QUIDEL CORPORATION
12544 HIGH BLUFF (ADMINISTRATIVE OFFICE LOCATION)
SAN DIEGO, CA 92130 US
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Contact
JOHN D TAMERIUS
Other 510(k) Applications for this Contact
Regulation Number
866.3740
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Classification Product Code
GTY
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More FDA Info for this Product Code
Date Received
07/01/2014
Decision Date
12/16/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Dual Track
Reviewed By Third Party
N
Expedited Review
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