Cleared Traditional

MACLEAN-FOGG, TISSUE CASSETTES

K833857 · Polymer Technology Corp. · Pathology
Dec 1983
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K833857 is an FDA 510(k) clearance for the MACLEAN-FOGG, TISSUE CASSETTES, a Cassettes, Tissue (Class I — General Controls, product code IDZ), submitted by Polymer Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1983, 25 days after receiving the submission on November 7, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K833857 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1983
Decision Date December 02, 1983
Days to Decision 25 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IDZ — Cassettes, Tissue
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3010