Cleared Traditional

MYCOPLASMA IGG

K033064 · Trinity Biotech USA · Microbiology

Nov 2003

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K033064 is an FDA 510(k) clearance for the MYCOPLASMA IGG, a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II — Special Controls, product code LON), 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 866.1645.

Submission Details

510(k) Number	K033064 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

Device Classification

Product Code	LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1645