Cleared Traditional

ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET

K890674 · Sigma Diagnostics, Inc. · Pathology
Feb 1989
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K890674 is an FDA 510(k) clearance for the ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET, a Wright's Stain (Class I — General Controls, product code IAF), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 24, 1989, 15 days after receiving the submission on February 9, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K890674 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1989
Decision Date February 24, 1989
Days to Decision 15 days
Submission Type Traditional
Review Panel Pathology (PA)
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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