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510(k) K203296

Device
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Applicant
Gold Standard Diagnostics
510(k) number
K203296
Product code
LSR
Decision
Substantially Equivalent (SESE)
Decision date
2021-03-22
Date received
2020-11-09
Regulation
866.3830
Classification name
Reagent, Borrelia Serological Reagent
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Napoleon Monce
Address
2851 Spafford St. Davis CA US 95618 95618

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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