Cleared Traditional

ZINC FORMALIN CONCENTRATE

K882268 · Anatech, Ltd. · Pathology
Jun 1988
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K882268 is an FDA 510(k) clearance for the ZINC FORMALIN CONCENTRATE, a Formaldehyde (formalin, Formol) (Class I — General Controls, product code IGG), submitted by Anatech, Ltd. (Battle Creek, US). The FDA issued a Cleared decision on June 15, 1988, 15 days after receiving the submission on May 31, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K882268 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1988
Decision Date June 15, 1988
Days to Decision 15 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IGG — Formaldehyde (formalin, Formol)
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010

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