Cleared Traditional

K960592 - ELECTROLYTE STANDARDS

K960592 is an FDA 510(k) clearance for ELECTROLYTE STANDARDS, 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 91-day FDA review.

K960592 · Phoenix Diagnostics, Inc. · Chemistry device
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May 1996
Decision
91d
Days
Class 1
Risk

K960592 is an FDA 510(k) clearance for the ELECTROLYTE STANDARDS. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Phoenix Diagnostics, Inc. (Natick, US). The FDA issued a Cleared decision on May 13, 1996 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Phoenix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K960592

510(k) Number K960592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1996
Decision Date May 13, 1996
Days to Decision 91 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
3d slower than avg
Panel avg: 88d · This submission: 91d
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
Devices cleared under the same product code (JJR) and FDA review panel - the closest regulatory comparables to K960592.
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K902266 · Phoenix Diagnostics, Inc. · Jun 1990
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K894576 · Ciba Corning Diagnostics Corp. · Oct 1989