Cleared Traditional

IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

K983605 · Columbia Bioscience, Inc. · Microbiology
Dec 1998
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K983605 is an FDA 510(k) clearance for the IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Columbia Bioscience, Inc. (Columbia, US). The FDA issued a Cleared decision on December 16, 1998, 63 days after receiving the submission on October 14, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K983605 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1998
Decision Date December 16, 1998
Days to Decision 63 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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