Cleared Traditional

HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS (K854236) - FDA 510(k) Clearance

Class I Chemistry device.

K854236 · Nms Pharmaceuticals, Inc. · Chemistry device
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Oct 1986
Decision
354d
Days
Class 1
Risk

K854236 is an FDA 510(k) clearance for the HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS. Classified as Wright's Stain (product code IAF), Class I - General Controls.

Submitted by Nms Pharmaceuticals, Inc. (Newport Beach, US). The FDA issued a Cleared decision on October 10, 1986 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.1850 - 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. Elevated predicate reliance profile. 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 Nms Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K854236 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 21, 1985
Decision Date October 10, 1986
Days to Decision 354 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
266d slower than avg
Panel avg: 88d · This submission: 354d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IAF Wright's Stain
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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.