Cleared Traditional

K874472 - INORGANIC PHOSPHORUS

K874472 is the FDA 510(k) clearance for INORGANIC PHOSPHORUS by Catachem, Inc.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K874472 · Catachem, Inc. · Chemistry device
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Dec 1987
Decision
50d
Days
Class 1
Risk

K874472 is an FDA 510(k) clearance for the INORGANIC PHOSPHORUS. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on December 22, 1987 after a review of 50 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 Catachem, Inc. devices

Submission Details

510(k) Number K874472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1987
Decision Date December 22, 1987
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 74
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K874472.
ROCHE REAGENT FOR INORGANIC PHOSPHORUS
K883962 · Roche Diagnostic Systems, Inc. · Nov 1988
PHOSPHORUS (INORGANIC)
K881171 · Tech-Co, Inc. · Apr 1988
KODAK EKTACHEM DT SLIDES (PHOS)
K874577 · Eastman Kodak Company · Jan 1988
PARAMAX PHOSPHORUS REAGENT
K873454 · Baxter Healthcare Corp · Nov 1987
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687
K874153 · Em Diagnostic Systems, Inc. · Nov 1987
PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION
K870368 · Trace Scientific , Ltd. · Aug 1987