Cleared Traditional

CHLAMYDIA (LGV-1)

K894625 · Bion Ent., Ltd. · Microbiology
Aug 1989
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K894625 is an FDA 510(k) clearance for the CHLAMYDIA (LGV-1), a Antisera, Fluorescent, Chlamydia Spp. (Class I — General Controls, product code LKI), submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on August 15, 1989, 26 days after receiving the submission on July 20, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K894625 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1989
Decision Date August 15, 1989
Days to Decision 26 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