Cleared Traditional

K854236 - HISTAMINE RIA TEST FOR HISTAMINE BIOLOG...

K854236 is the FDA 510(k) clearance for HISTAMINE RIA TEST FOR HISTAMINE BIOLOG... by Nms Pharmaceuticals, Inc.. It is a Class 1 Chemistry device (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

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.

Regulatory Peers - IAF Wright's Stain

All 12
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
MIDAS 1000 WRIGHT STAIN #66010
K822980 · Emd Chemicals, Inc. · Oct 1982