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510(k) K183446

BioPlex 2200 Lyme Total by Bio-Rad Laboratories — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2019
Date Received
December 12, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Borrelia Serological Reagent
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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