Cleared Traditional

IMMUNODOT BORRELIA (LYME) TEST

K911627 · General Biometrics, Inc. · Microbiology
Apr 1992
Decision
363d
Days
Class 2
Risk

About This 510(k) Submission

K911627 is an FDA 510(k) clearance for the IMMUNODOT BORRELIA (LYME) TEST, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 8, 1992, 363 days after receiving the submission on April 11, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K911627 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1991
Decision Date April 08, 1992
Days to Decision 363 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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