Cleared Traditional

K864313 - CO2 REAGENT SET

K864313 is an FDA 510(k) clearance for CO2 REAGENT SET, manufactured by Hf Scientific, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K864313

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.

CIE Device Classification - Class 2, Special Controls

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