Cleared Traditional

EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL

K850431 · Nms Pharmaceuticals, Inc. · Hematology
Jun 1985
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K850431 is an FDA 510(k) clearance for the EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Nms Pharmaceuticals, Inc. (Newport Beach, US). The FDA issued a Cleared decision on June 17, 1985, 133 days after receiving the submission on February 4, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K850431 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1985
Decision Date June 17, 1985
Days to Decision 133 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KHE — Reagent, Occult Blood
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6550

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