Cleared Traditional

K863264 - INORGANIC PHOSPHORUS PROCEDURE

K863264 is the FDA 510(k) clearance for INORGANIC PHOSPHORUS PROCEDURE by Data Medical Associates, Inc.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K863264 · Data Medical Associates, Inc. · Chemistry device

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Sep 1986

Decision

17d

Days

Class 1

Risk

K863264 is an FDA 510(k) clearance for the INORGANIC PHOSPHORUS 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 September 11, 1986 after a review of 17 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	K863264 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 25, 1986
Decision Date	September 11, 1986
Days to Decision	17 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

71d faster than avg

Panel avg: 88d · This submission: 17d

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 K863264.

RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT

K870776 · Reagents Applications, Inc. · Mar 1987

EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95

K863718 · Em Diagnostic Systems, Inc. · Oct 1986

ABBOTT SPECTRUM PHOSPHORUS REAGENT

K863088 · Abbott Laboratories · Sep 1986

FOSFOROMETER

K863072 · J. D. Assoc. · Sep 1986

MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT

K862834 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1986

INORGANIC PHOSPHORUS PROCEDURE

K861661 · Data Medical Associates, Inc. · Jul 1986

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K863264

Data Medical Associates, Inc.

Arlington, TX · US

MARJORIE B POTTS

Regulatory profile

111 submissions 111 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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