Cleared Traditional

AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET (K861968) - FDA 510(k) Clearance

Class I Chemistry device.

K861968 · American Research Products Co. · Chemistry device
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Jun 1986
Decision
24d
Days
Class 1
Risk

K861968 is an FDA 510(k) clearance for the AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on June 13, 1986 after a review of 24 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 American Research Products Co. devices

Submission Details

510(k) Number K861968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1986
Decision Date June 13, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
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 26
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K861968.
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687
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ABBOTT SPECTRUM PHOSPHORUS REAGENT
K863088 · Abbott Laboratories · Sep 1986
SYSTEMATE PHOSPHORUS 67217
K843330 · Em Diagnostic Systems, Inc. · Sep 1984
ASTRA SYS INORGANIC PHOSPHORUS CHEM
K841181 · Beckman Instruments, Inc. · May 1984
REAGENT SYSTEM, INORGANIC PHOSPHORUS
K781806 · Sigma Chemical Co. · Jan 1979