Cleared Traditional

K832079 - COLLECTION KIT CHLAMYDIA TRACHOMATIS

K832079 is an FDA 510(k) clearance for COLLECTION KIT CHLAMYDIA TRACHOMATIS, manufactured by Syva Co.. The device is a Class 1 Microbiology device with product code LIO cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K832079 · Syva Co. · Microbiology device
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Sep 1983
Decision
93d
Days
Class 1
Risk

K832079 is an FDA 510(k) clearance for the COLLECTION KIT CHLAMYDIA TRACHOMATIS. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 93 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.

FDA 510(k) Submission Details - K832079

510(k) Number K832079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1983
Decision Date September 29, 1983
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

LIO Device Classification - Class 1, General Controls

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.

Regulatory Peers - LIO Device, Specimen Collection

All 58
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K832079.
SANI CATCH BA
K833814 · Concord Laboratories, Inc. · Mar 1984
PRESERV SAF FIXATIVE 15ML
K834566 · Preventive Diagnostics Corp. · Feb 1984
PRESERV MF FIXATIVE 15ML
K840086 · Preventive Diagnostics Corp. · Jan 1984
DUPONT ISOLATOR 1.5 MICROBIAL TUBE
K832246 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983
VD ALERT
K820520 · Intl. Research Distributors, Inc. · May 1982
K832079 · COLLECTION KIT CHLAMYDIA TRACHOMATIS
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