Cleared Traditional

K801745 - VISTA 44 GAS CHROMATOGRAPHY ANALYSIS

K801745 is the FDA 510(k) clearance for VISTA 44 GAS CHROMATOGRAPHY ANALYSIS by Varian Assoc., Inc.. It is a Class 1 Chemistry device (product code KZQ) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K801745 · Varian Assoc., Inc. · Chemistry device
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Aug 1980
Decision
23d
Days
Class 1
Risk

K801745 is an FDA 510(k) clearance for the VISTA 44 GAS CHROMATOGRAPHY ANALYSIS. Classified as Chromatography(gas), Clinical Use (product code KZQ), Class I - General Controls.

Submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2250 - the FDA in vitro diagnostics and chemistry 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 Varian Assoc., Inc. devices

Submission Details

510(k) Number K801745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date August 20, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZQ Chromatography(gas), Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2250
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 - KZQ Chromatography(gas), Clinical Use

All 9
Devices cleared under the same product code (KZQ) and FDA review panel - the closest regulatory comparables to K801745.
SIGMA 300 GAS CHROMATROGRAPH
K830147 · The Perkin-Elmer Corp. · Feb 1983
SIGMA 2000 GAS CHROMATOGRAPH
K820283 · The Perkin-Elmer Corp. · Feb 1982
MODEL 5790 GAS CHROMATOGRAPH
K820071 · Hewlett-Packard Co. · Jan 1982
5880 SERIES OF GAS CHROMATOGRAPHS
K791138 · Hewlett-Packard Co. · Jul 1979
GAS CHROMOTOGRAPHS, SIGMA 1,2,3,4,&10
K770025 · The Perkin-Elmer Corp. · Feb 1977