510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203289Substantially Equivalent

Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit

Gold Standard Diagnostics, LLC, Davis CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203289 is the FDA 510(k) clearance record for Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit, a class II device, cleared for Gold Standard Diagnostics on under FDA product code LSR (Reagent, Borrelia Serological Reagent). FDA records list 15 510(k) clearances for Gold Standard Diagnostics, from to . As of , FDA records show no recalls naming K203289.

Clearance record

Decision date
Received
(133 days to decision)
Product code
LSR Reagent, Borrelia Serological Reagent
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Gold Standard Diagnostics 2851 Spafford St., Davis CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LSR

Trailing 12 months
2 clearances under product code LSR in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LSR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260