Cleared Traditional

K855154 - INORGANIC PHOSPHORUS REAGENT SET

K855154 is an FDA 510(k) clearance for INORGANIC PHOSPHORUS REAGENT SET, manufactured by Technostics Intl.. The device is a Class 1 Chemistry device with product code CEO cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K855154 · Technostics Intl. · Chemistry device
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Jan 1986
Decision
19d
Days
Class 1
Risk

K855154 is an FDA 510(k) clearance for the INORGANIC PHOSPHORUS REAGENT SET. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 19 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 Technostics Intl. devices

FDA 510(k) Submission Details - K855154

510(k) Number K855154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date January 14, 1986
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

CEO Device Classification - Class 1, General Controls

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 96
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K855154.
INORGANIC PHOSPHORUS PROCEDURE
K861661 · Data Medical Associates, Inc. · Jul 1986
AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET
K861968 · American Research Products Co. · Jun 1986
INORGANIC PHOSPHORUS REAGENT SET
K860628 · Sterling Diagnostics, Inc. · Mar 1986
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO
K854188 · Clinical Data, Inc. · Nov 1985
IP ACID REAGENT IP MOLY BDATE REAGENT
K852003 · Alpkem Corp. · May 1985
INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN
K852103 · Medical Analysis Systems, Inc. · May 1985