Cleared Traditional

K881436 - SODIUM/POTASSIUM SERUM RANGE LINEARITY ...

K881436 is the FDA 510(k) clearance for SODIUM/POTASSIUM SERUM RANGE LINEARITY ... by Hichem Diagnostics. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K881436 · Hichem Diagnostics · Chemistry device
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Jun 1988
Decision
58d
Days
Class 1
Risk

K881436 is an FDA 510(k) clearance for the SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on June 2, 1988 after a review of 58 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K881436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1988
Decision Date June 02, 1988
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 472
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K881436.
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