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FDA 510(k) Application Details - K203296
Device Classification Name
Reagent, Borrelia Serological Reagent
More FDA Info for this Device
510(K) Number
K203296
Device Name
Reagent, Borrelia Serological Reagent
Applicant
Gold Standard Diagnostics
2851 Spafford St.
Davis, CA 95618 US
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Contact
Napoleon Monce
Other 510(k) Applications for this Contact
Regulation Number
866.3830
More FDA Info for this Regulation Number
Classification Product Code
LSR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/09/2020
Decision Date
03/22/2021
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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