Cleared Traditional

K781806 - REAGENT SYSTEM

K781806 is the FDA 510(k) clearance for REAGENT SYSTEM by Sigma Chemical Co.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K781806 · Sigma Chemical Co. · Chemistry device
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Jan 1979
Decision
84d
Days
Class 1
Risk

K781806 is an FDA 510(k) clearance for the REAGENT SYSTEM, INORGANIC PHOSPHORUS. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1979 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1580 - 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K781806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1978
Decision Date January 17, 1979
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1580
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 - CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus

All 73
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K781806.
ELVI INORGANIC PHOSPHOROUS
K792401 · Volu Sol Medical Industries · Dec 1979
INORGANIC PHOSPHORUS REAGENT
K791708 · Gilford Diagnostics · Sep 1979
SERUM, INORGANIC PHOSPHOROUS
K790021 · Fisher Scientific Co., LLC · Feb 1979
PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS
K781000 · Abbott Laboratories · Dec 1978
ULTRACHEM PHOSPHORUS, 64973
K772156 · Harleco · Dec 1977
PHOSPHORUS TEST KIT
K771848 · Mallinckrodt Critical Care · Oct 1977