Cleared Traditional

HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES

K890281 · Cambridge Bioscience Corp. · Microbiology
Mar 1989
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K890281 is an FDA 510(k) clearance for the HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Cambridge Bioscience Corp. (Worcester, US). The FDA issued a Cleared decision on March 15, 1989, 57 days after receiving the submission on January 17, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K890281 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1989
Decision Date March 15, 1989
Days to Decision 57 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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