Cleared Traditional

ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION

K883048 · Alpha-Tec Systems, Inc. · Pathology
Aug 1988
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K883048 is an FDA 510(k) clearance for the ATS PARA-SET MODIFIED 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 August 17, 1988, 32 days after receiving the submission on July 16, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K883048 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1988
Decision Date August 17, 1988
Days to Decision 32 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