Cleared Traditional

MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES

K854615 · Serono Diagnostics, Inc. · Microbiology
Jan 1986
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K854615 is an FDA 510(k) clearance for the MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES, a Antisera, Fluorescent, Chlamydia Spp. (Class I — General Controls, product code LKI), submitted by Serono Diagnostics, Inc. (Bramtree, US). The FDA issued a Cleared decision on January 28, 1986, 71 days after receiving the submission on November 18, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K854615 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1985
Decision Date January 28, 1986
Days to Decision 71 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LKI — Antisera, Fluorescent, Chlamydia Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120