Cleared Traditional

K850986 - DATE CHEM INORGANIC PHOSPHOROUS U.V. PR...

K850986 is the FDA 510(k) clearance for DATE CHEM INORGANIC PHOSPHOROUS U.V. PR... by Data Medical Associates, Inc.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K850986 · Data Medical Associates, Inc. · Chemistry device
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Apr 1985
Decision
21d
Days
Class 1
Risk

K850986 is an FDA 510(k) clearance for the DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on April 1, 1985 after a review of 21 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K850986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1985
Decision Date April 01, 1985
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
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 K850986.
INORGANIC PHOSPHORUS REAGENT SET
K860628 · Sterling Diagnostics, Inc. · Mar 1986
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO
K854188 · Clinical Data, Inc. · Nov 1985
INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN
K852103 · Medical Analysis Systems, Inc. · May 1985
RAICHEM PHOSPHORUS REAGENT
K844316 · Reagents Applications, Inc. · Jan 1985
INORGANIC PHOSPHORUS TEST
K843177 · Sclavo, Inc. · Sep 1984
SYSTEMATE PHOSPHORUS 67217
K843330 · Em Diagnostic Systems, Inc. · Sep 1984