Cleared Traditional

BIOFIX

K843428 · Accra Laboratories, Inc. · Pathology
Sep 1984
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K843428 is an FDA 510(k) clearance for the BIOFIX, a Fixative, Alcohol Containing (Class I — General Controls, product code LDZ), submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984, 23 days after receiving the submission on September 4, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K843428 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1984
Decision Date September 27, 1984
Days to Decision 23 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code LDZ — Fixative, Alcohol Containing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010

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