Cleared Traditional

LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)

K971006 · Mrl Diagnostics · Microbiology
Jun 1998
Decision
439d
Days
Class 2
Risk

About This 510(k) Submission

K971006 is an FDA 510(k) clearance for the LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G), a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Mrl Diagnostics (Cypress, US). The FDA issued a Cleared decision on June 1, 1998, 439 days after receiving the submission on March 19, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K971006 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 1997
Decision Date June 01, 1998
Days to Decision 439 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSR — Reagent, Borrelia Serological Reagent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

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