Cleared Traditional

HEMATOLOGY STAIN PACK

K853241 · Fisher Scientific Co., LLC · Pathology
Aug 1985
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K853241 is an FDA 510(k) clearance for the HEMATOLOGY STAIN PACK, a Wright's Stain (Class I — General Controls, product code IAF), submitted by Fisher Scientific Co., LLC (Fair Lawn, US). The FDA issued a Cleared decision on August 19, 1985, 18 days after receiving the submission on August 1, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K853241 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1985
Decision Date August 19, 1985
Days to Decision 18 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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