Cleared Traditional

HEMACOUNT WRIGHTS STAIN PACK II #55952

K821457 · Accra Laboratories, Inc. · Hematology
Jun 1982
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K821457 is an FDA 510(k) clearance for the HEMACOUNT WRIGHTS STAIN PACK II #55952, 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 1, 1982, 15 days after receiving the submission on May 17, 1982. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K821457 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1982
Decision Date June 01, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel Hematology (HE)
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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