Cleared Abbreviated

K023567 - STAT PROFILE PHOX PLUS L ANALYZER

K023567 is the FDA 510(k) clearance for STAT PROFILE PHOX PLUS L ANALYZER by Nova Biomedical Corp.. It is a Class 2 Chemistry device (product code CHL) cleared through the Abbreviated 510(k) pathway after a 58-day FDA review.

K023567 · Nova Biomedical Corp. · Chemistry device
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Dec 2002
Decision
58d
Days
Class 2
Risk

K023567 is an FDA 510(k) clearance for the STAT PROFILE PHOX PLUS L ANALYZER. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on December 20, 2002 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nova Biomedical Corp. devices

Submission Details

510(k) Number K023567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2002
Decision Date December 20, 2002
Days to Decision 58 days
Submission Type Abbreviated
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
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

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