Cleared Traditional

IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY

K914953 · Stellar Bio Systems, Inc. · Microbiology
Feb 1992
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K914953 is an FDA 510(k) clearance for the IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY, a Antisera, Fluorescent, Chlamydia Spp. (Class I — General Controls, product code LKI), submitted by Stellar Bio Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on February 19, 1992, 106 days after receiving the submission on November 5, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K914953 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1991
Decision Date February 19, 1992
Days to Decision 106 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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