Cleared Traditional

HEMAQUIK II STAINING SOLUTION #55961

K830542 · Accra Laboratories, Inc. · Pathology
Mar 1983
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K830542 is an FDA 510(k) clearance for the HEMAQUIK II STAINING SOLUTION #55961, 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 March 17, 1983, 23 days after receiving the submission on February 22, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K830542 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1983
Decision Date March 17, 1983
Days to Decision 23 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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