Cleared Traditional

K944768 - OLYMPUS INORGANIC PHOSPHORUS REAGENT (FDA 510(k) Clearance)

Class I Chemistry device.

K944768 · Olympus America, Inc. · Chemistry device
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Mar 1995
Decision
178d
Days
Class 1
Risk

K944768 is an FDA 510(k) clearance for the OLYMPUS INORGANIC PHOSPHORUS REAGENT. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 178 days - an extended review 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: 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 Olympus America, Inc. devices

Submission Details

510(k) Number K944768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1994
Decision Date March 24, 1995
Days to Decision 178 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 88d · This submission: 178d
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.