Cleared Traditional

CULUTURE SET CHLAMYDIA ISOLATION AND

K830342 · Immulok, Inc. · Microbiology
May 1983
Decision
92d
Days
Class 1
Risk

About This 510(k) Submission

K830342 is an FDA 510(k) clearance for the CULUTURE SET CHLAMYDIA ISOLATION AND, a Antisera, Fluorescent, Chlamydia Spp. (Class I — General Controls, product code LKI), submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 4, 1983, 92 days after receiving the submission on February 1, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K830342 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1983
Decision Date May 04, 1983
Days to Decision 92 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