Cleared Traditional

K902266 - ELECTROLYTE CONTROLS (ASSAYED AND UNASS...

K902266 is an FDA 510(k) clearance for ELECTROLYTE CONTROLS (ASSAYED AND UNASS..., manufactured by Phoenix Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJR cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K902266 · Phoenix Diagnostics, Inc. · Chemistry device
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Jun 1990
Decision
16d
Days
Class 1
Risk

K902266 is an FDA 510(k) clearance for the ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED). Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Phoenix Diagnostics, Inc. (Medfield, US). The FDA issued a Cleared decision on June 6, 1990 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Phoenix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K902266

510(k) Number K902266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1990
Decision Date June 06, 1990
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

JJR Device Classification - Class 1, General Controls

Product Code JJR Electrolyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJR Electrolyte Controls (assayed And Unassayed)

All 11
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