Cleared Traditional

K834566 - PRESERV SAF FIXATIVE 15ML

K834566 is an FDA 510(k) clearance for PRESERV SAF FIXATIVE 15ML, manufactured by Preventive Diagnostics Corp.. The device is a Class 1 Microbiology device with product code LIO cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K834566 · Preventive Diagnostics Corp. · Microbiology device
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Feb 1984
Decision
38d
Days
Class 1
Risk

K834566 is an FDA 510(k) clearance for the PRESERV SAF FIXATIVE 15ML. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Preventive Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Preventive Diagnostics Corp. devices

FDA 510(k) Submission Details - K834566

510(k) Number K834566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1983
Decision Date February 04, 1984
Days to Decision 38 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
64d faster than avg
Panel avg: 102d · This submission: 38d
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 35
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K834566.
IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K862607 · Boots-Celltech Diagnostics, Inc. · Aug 1986
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST
K843935 · Syva Co. · Oct 1984
SANI CATCH BA
K833814 · Concord Laboratories, Inc. · Mar 1984
PRESERV MF FIXATIVE 15ML
K840086 · Preventive Diagnostics Corp. · Jan 1984
COLLECTION KIT CHLAMYDIA TRACHOMATIS
K832079 · Syva Co. · Sep 1983
DUPONT ISOLATOR 1.5 MICROBIAL TUBE
K832246 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983