Cleared Traditional

IMMUNOWELL LYME (P39 RECOMBINANT) TEST

K911599 · General Biometrics, Inc. · Microbiology
Dec 1991
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K911599 is an FDA 510(k) clearance for the IMMUNOWELL LYME (P39 RECOMBINANT) 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 December 30, 1991, 265 days after receiving the submission on April 9, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K911599 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1991
Decision Date December 30, 1991
Days to Decision 265 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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