Cleared Traditional

K864313 - CO2 REAGENT SET

K864313 is the FDA 510(k) clearance for CO2 REAGENT SET by Hf Scientific, Inc.. It is a Class 2 Chemistry device (product code CIE) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K864313 · Hf Scientific, Inc. · Chemistry device
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Mar 1987
Decision
130d
Days
Class 2
Risk

K864313 is an FDA 510(k) clearance for the CO2 REAGENT SET. Classified as Volumetric/manometric, Carbon-dioxide (product code CIE), Class II - Special Controls.

Submitted by Hf Scientific, Inc. (Ft. Myers, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Hf Scientific, Inc. devices

Submission Details

510(k) Number K864313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1986
Decision Date March 13, 1987
Days to Decision 130 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 88d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIE Volumetric/manometric, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIE Volumetric/manometric, Carbon-dioxide

Devices cleared under the same product code (CIE) and FDA review panel - the closest regulatory comparables to K864313.
P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT
K904761 · Instrumentation Laboratory CO · Nov 1990
TOTAL CO2 REAGENT SET
K832071 · American Research Products Co. · Aug 1983
SERALYZER REFLECTANCE PHOTOMETER/CALIB.
K800524 · Miles Laboratories, Inc. · Apr 1980
CARBON DIOXIDE ANALYZER
K771610 · Corning Medical & Scientific · Oct 1977