Cleared Traditional

ACCRA LAB HEMOTOLOGY

K812848 · Accra Laboratories, Inc. · Pathology
Oct 1981
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K812848 is an FDA 510(k) clearance for the ACCRA LAB HEMOTOLOGY, 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 October 23, 1981, 14 days after receiving the submission on October 9, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K812848 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 1981
Decision Date October 23, 1981
Days to Decision 14 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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