Cleared Traditional

K833814 - SANI CATCH BA (FDA 510(k) Clearance)

Class I Microbiology device.

K833814 · Concord Laboratories, Inc. · Microbiology device
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Mar 1984
Decision
138d
Days
Class 1
Risk

K833814 is an FDA 510(k) clearance for the SANI CATCH BA. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Concord Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Concord Laboratories, Inc. devices

Submission Details

510(k) Number K833814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1983
Decision Date March 19, 1984
Days to Decision 138 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 102d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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.