Cleared Special

RAICHEM PHOSPORUS REAGENT (K003012) - FDA 510(k) Clearance

Class I Chemistry device.

K003012 · Hemagen Diagnostics, Inc. · Chemistry device
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Oct 2000
Decision
29d
Days
Class 1
Risk

K003012 is an FDA 510(k) clearance for the RAICHEM PHOSPORUS REAGENT. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hemagen Diagnostics, Inc. devices

Submission Details

510(k) Number K003012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2000
Decision Date October 25, 2000
Days to Decision 29 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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

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