Cleared Traditional

K854236 - HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS

K854236 is an FDA 510(k) clearance for HISTAMINE RIA TEST FOR HISTAMINE BIOLOG..., manufactured by Nms Pharmaceuticals, Inc.. The device is a Class 1 Chemistry device with product code IAF cleared through the Traditional 510(k) pathway after a 354-day FDA review.

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

FDA 510(k) Submission Details - K854236

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.

IAF Device Classification - Class 1, General Controls

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.

Regulatory Peers - IAF Wright's Stain

All 19
Devices cleared under the same product code (IAF) and FDA review panel - the closest regulatory comparables to K854236.
WRIGHT-GLEMSA STAIN
K890673 · Sigma Diagnostics, Inc. · Feb 1989
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
K890674 · Sigma Diagnostics, Inc. · Feb 1989
HEMATOLOGY STAIN PACK
K853241 · Fisher Scientific Co., LLC · Aug 1985
WRIGHT STAIN
K842744 · E K Ind., Inc. · Aug 1984
WRIGHT-GIEMSA QUICK STAIN
K842745 · E K Ind., Inc. · Aug 1984
HEMATOLOGY WRIGHT'S STAIN PACK
K833678 · J.S. Medical Assoc. · Nov 1983