Cleared Traditional

K770456 - PHOSPHOROUS

K770456 is the FDA 510(k) clearance for PHOSPHOROUS by Icn Pharmaceuticals, Inc.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K770456 · Icn Pharmaceuticals, Inc. · Chemistry device
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May 1977
Decision
56d
Days
Class 1
Risk

K770456 is an FDA 510(k) clearance for the PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Icn Pharmaceuticals, Inc. (Orangeburg, US). The FDA issued a Cleared decision on May 3, 1977 after a review of 56 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 Icn Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K770456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1977
Decision Date May 03, 1977
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
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 50
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K770456.
PHOSPHORUS TEST KIT
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K771477 · Instrumentation Laboratory CO · Sep 1977
ULTRACHEM INORGANIC PHOSPHORUS
K770820 · Harleco · Jul 1977
AUTO-INORGANIC PHOSPHORUS REAGENT
K761238 · Harleco · Dec 1976
AUTO-INORGANIC PHOSPHORUS REAGENT
K761239 · Harleco · Dec 1976
ACA PHOSPHORUS ANALYTICAL TEST PACK
K760634 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1976