Cleared Traditional

K924590 - MICROWAVE AUTOMATED TISSUE PROCESSOR
(FDA 510(k) Clearance)

Dec 1992
Decision
110d
Days
Class 1
Risk

K924590 is an FDA 510(k) clearance for the MICROWAVE AUTOMATED TISSUE PROCESSOR. This device is classified as a Processor, Tissue, Automated (Class I - General Controls, product code IEO).

Submitted by Innovative Medical Systems, Inc. (Ivyland, US). The FDA issued a Cleared decision on December 29, 1992, 110 days after receiving the submission on September 10, 1992.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3875.

Submission Details

510(k) Number K924590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1992
Decision Date December 29, 1992
Days to Decision 110 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement

Device Classification

Product Code IEO — Processor, Tissue, Automated
Device Class Class I - General Controls
CFR Regulation 21 CFR 864.3875

Similar Devices — IEO Processor, Tissue, Automated

All 11
LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC)
K883599 · Innovative Medical Systems, Inc. · Sep 1988
SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR
K881165 · Sakura Finetek U.S.A., Inc. · Jul 1988
LX 300 TISSUE PROCESSOR
K853938 · Innovative Medical Systems, Inc. · Oct 1985
LX120 TISSUE PROCESSOR
K851054 · Innovative Medical Systems, Inc. · May 1985
LKB 2189 ULTROPROCESSOR
K843506 · Lkb Instruments, Inc. · Nov 1984
AUTOTECHNICON V TISSUE PROCESS SYS
K834599 · Technicon Instruments Corp. · Feb 1984