Cleared Traditional

K901807 - OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT...

K901807 is the FDA 510(k) clearance for OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT... by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K901807 · Em Diagnostic Systems, Inc. · Chemistry device
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May 1990
Decision
12d
Days
Class 1
Risk

K901807 is an FDA 510(k) clearance for the OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.). Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 12 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K901807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1990
Decision Date May 02, 1990
Days to Decision 12 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
76d faster than avg
Panel avg: 88d · This submission: 12d
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 K901807.
SYNERMED PHOSPHORUS REAGENT KIT
K912569 · Synermed, Inc. · Jul 1991
OLYMPUS INORGANIC PHOSPHORUS
K903696 · Em Diagnostic Systems, Inc. · Sep 1990
PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463
K901964 · American Research Products Co. · May 1990
CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)
K901137 · Technicon Instruments Corp. · Apr 1990
AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500
K900977 · American Research Products Co. · Apr 1990
COULTER PHOSPHORUS REAGENT
K900215 · Coulter Corp. · Feb 1990