Cleared Traditional

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

K991074 · Intracel Corp. · Microbiology
Dec 1999
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K991074 is an FDA 510(k) clearance for the BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST, a Legionella, Spp., Elisa (Class II — Special Controls, product code MJH), submitted by Intracel Corp. (Rockville, US). The FDA issued a Cleared decision on December 21, 1999, 265 days after receiving the submission on March 31, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number K991074 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1999
Decision Date December 21, 1999
Days to Decision 265 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MJH — Legionella, Spp., Elisa
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3300

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