Cleared Traditional

K923564 - OLYMPUS INORGANIC PHOSPHORUS REAGENT

K923564 is the FDA 510(k) clearance for OLYMPUS INORGANIC PHOSPHORUS REAGENT by Olympus Corp.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K923564 · Olympus Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
32d
Days
Class 1
Risk

K923564 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 Corp. (Lake Success, US). The FDA issued a Cleared decision on August 18, 1992 after a review of 32 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 Olympus Corp. devices

Submission Details

510(k) Number K923564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1992
Decision Date August 18, 1992
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K923564.
OLYMPUS INORGANIC PHOSPHORUS REAGENT
K925057 · Olympus Corp. · Nov 1992
TWO PART INORGANIC PHOSPHORUS TEST
K924470 · Em Diagnostic Systems, Inc. · Oct 1992
SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000
K923764 · Em Diagnostic Systems, Inc. · Sep 1992
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14
K912809 · Em Diagnostic Systems, Inc. · Aug 1991
SYNERMED PHOSPHORUS REAGENT KIT
K912569 · Synermed, Inc. · Jul 1991
OLYMPUS INORGANIC PHOSPHORUS
K903696 · Em Diagnostic Systems, Inc. · Sep 1990