Cleared Traditional

ACCRA LAB WRIGHT STAIN

K812504 · Accra Laboratories, Inc. · Pathology
Sep 1981
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K812504 is an FDA 510(k) clearance for the ACCRA LAB WRIGHT STAIN, a Wright's Stain (Class I — General Controls, product code IAF), submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981, 22 days after receiving the submission on September 1, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K812504 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1981
Decision Date September 23, 1981
Days to Decision 22 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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