Cleared Traditional

LYME IGM ELISA TEST

K903013 · Gull Laboratories, Inc. · Microbiology
Jun 1991
Decision
345d
Days
Class 2
Risk

About This 510(k) Submission

K903013 is an FDA 510(k) clearance for the LYME IGM ELISA TEST, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 21, 1991, 345 days after receiving the submission on July 11, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K903013 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1990
Decision Date June 21, 1991
Days to Decision 345 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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