Cleared Traditional

K925612 - HI CHEM ELECTROLYTE BUFFER

K925612 is the FDA 510(k) clearance for HI CHEM ELECTROLYTE BUFFER by Hichem Diagnostics. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K925612 · Hichem Diagnostics · Chemistry device
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Apr 1993
Decision
166d
Days
Class 2
Risk

K925612 is an FDA 510(k) clearance for the HI CHEM ELECTROLYTE BUFFER. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 166 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 Hichem Diagnostics devices

Submission Details

510(k) Number K925612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1992
Decision Date April 20, 1993
Days to Decision 166 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
78d slower than avg
Panel avg: 88d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 115
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K925612.
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HI CHEM ELECTROLYTE REFERENCE REAGENT
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K924471 · Eastman Kodak Company · Nov 1992