Cleared Traditional

K931834 - KING SODIUM/POTASSIUM STANDARD MODIFIED

K931834 is the FDA 510(k) clearance for KING SODIUM/POTASSIUM STANDARD MODIFIED by King Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K931834 · King Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
152d
Days
Class 2
Risk

K931834 is an FDA 510(k) clearance for the KING SODIUM/POTASSIUM STANDARD MODIFIED. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 25, 1993 after a review of 152 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 King Diagnostics, Inc. devices

Submission Details

510(k) Number K931834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1993
Decision Date August 25, 1993
Days to Decision 152 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 88d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K931834.
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K930477 · Analytical Control Systems, Inc. · Jun 1993