Cleared Traditional

TISSUE PROCESSING CASSETTES & ACCESS

K813430 · American Optical Corp. · Pathology
Dec 1981
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K813430 is an FDA 510(k) clearance for the TISSUE PROCESSING CASSETTES & ACCESS, a Microtome, Accessories (Class I — General Controls, product code IDL), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on December 29, 1981, 21 days after receiving the submission on December 8, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K813430 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1981
Decision Date December 29, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IDL — Microtome, Accessories
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3010