Cleared Traditional

HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS

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

About This 510(k) Submission

K854236 is an FDA 510(k) clearance for the HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS, a Wright's Stain (Class I — General Controls, product code IAF), submitted by Nms Pharmaceuticals, Inc. (Newport Beach, US). The FDA issued a Cleared decision on October 10, 1986, 354 days after receiving the submission on October 21, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K854236 FDA.gov
FDA Decision Cleared SN
Date Received October 21, 1985
Decision Date October 10, 1986
Days to Decision 354 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code IAF — Wright's Stain
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850

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