Cleared Traditional

K830342 - CULUTURE SET CHLAMYDIA ISOLATION AND (FDA 510(k) Clearance)

Class I Microbiology device.

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

K830342 is an FDA 510(k) clearance for the CULUTURE SET CHLAMYDIA ISOLATION AND. Classified as Antisera, Fluorescent, Chlamydia Spp. (product code LKI), Class I - General Controls.

Submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 4, 1983 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immulok, Inc. devices

Submission Details

510(k) Number K830342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1983
Decision Date May 04, 1983
Days to Decision 92 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 102d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKI Antisera, Fluorescent, Chlamydia Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.