Cleared Traditional

K033083 - BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
(FDA 510(k) Clearance)

K033083 · Trinity Biotech USA · Microbiology

Nov 2003

Decision

58d

Days

Class 2

Risk

K033083 is an FDA 510(k) clearance for the BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on November 26, 2003, 58 days after receiving the submission on September 29, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number	K033083 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2003
Decision Date	November 26, 2003
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF