Cleared Traditional

SAF FIXATIVE

K831058 · American Micro Scan · Pathology
Jun 1983
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K831058 is an FDA 510(k) clearance for the SAF FIXATIVE, a Fixative, Acid Containing (Class I — General Controls, product code LDW), submitted by American Micro Scan (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983, 68 days after receiving the submission on April 1, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K831058 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1983
Decision Date June 08, 1983
Days to Decision 68 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code LDW — Fixative, Acid Containing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010