Cleared Traditional

KOH MOUNTING FLUID

K812193 · American Scientific Products · Microbiology
Aug 1981
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K812193 is an FDA 510(k) clearance for the KOH MOUNTING FLUID, a Mounting Media (Class I — General Controls, product code LEB), submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981, 28 days after receiving the submission on August 3, 1981. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K812193 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1981
Decision Date August 31, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LEB — Mounting Media
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010