Cleared Traditional

K901137 - CHEM 1 CLINICAL ANALYZER (URINE INORGAN...

K901137 is the FDA 510(k) clearance for CHEM 1 CLINICAL ANALYZER (URINE INORGAN... by Technicon Instruments Corp.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K901137 · Technicon Instruments Corp. · Chemistry device
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Apr 1990
Decision
31d
Days
Class 1
Risk

K901137 is an FDA 510(k) clearance for the CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO). Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on April 12, 1990 after a review of 31 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K901137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date April 12, 1990
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 73
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K901137.
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
OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)
K901807 · Em Diagnostic Systems, Inc. · May 1990
AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500
K900977 · American Research Products Co. · Apr 1990
COULTER PHOSPHORUS REAGENT
K900215 · Coulter Corp. · Feb 1990
PHOSPHORUS
K895999 · American Monitor Corp. · Jan 1990