Cleared Traditional

FIAX LYME M TEST KIT

K904893 · Whittaker Bioproducts, Inc. · Microbiology
Oct 1991
Decision
351d
Days
Class 2
Risk

About This 510(k) Submission

K904893 is an FDA 510(k) clearance for the FIAX LYME M TEST KIT, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on October 16, 1991, 351 days after receiving the submission on October 30, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K904893 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 1990
Decision Date October 16, 1991
Days to Decision 351 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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