Cleared Traditional

ATS PVA FIXATIVE SOLUTION

K881698 · Alpha-Tec Systems, Inc. · Pathology
May 1988
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K881698 is an FDA 510(k) clearance for the ATS PVA FIXATIVE SOLUTION, a Fixative, Alcohol Containing (Class I — General Controls, product code LDZ), submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on May 13, 1988, 24 days after receiving the submission on April 19, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K881698 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1988
Decision Date May 13, 1988
Days to Decision 24 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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