Cleared Traditional

HEMAQUIK

K811400 · Accra Laboratories, Inc. · Pathology
Jun 1981
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K811400 is an FDA 510(k) clearance for the HEMAQUIK, 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 June 18, 1981, 31 days after receiving the submission on May 18, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K811400 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1981
Decision Date June 18, 1981
Days to Decision 31 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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