Cleared Traditional

K850934 - PHOSPHORUS

K850934 is the FDA 510(k) clearance for PHOSPHORUS by Dilab, Inc.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K850934 · Dilab, Inc. · Chemistry device
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Jun 1985
Decision
110d
Days
Class 1
Risk

K850934 is an FDA 510(k) clearance for the PHOSPHORUS. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Dilab, Inc. devices

Submission Details

510(k) Number K850934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date June 25, 1985
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
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 76
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K850934.
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
DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE
K850986 · Data Medical Associates, Inc. · Apr 1985