Cleared Traditional

LX-100 SLIDE STAINER

K880745 · Innovative Medical Systems, Inc. · Hematology
Apr 1988
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K880745 is an FDA 510(k) clearance for the LX-100 SLIDE STAINER, a Slide Stainer, Automated (Class I — General Controls, product code KPA), submitted by Innovative Medical Systems, Inc. (Ivyland, US). The FDA issued a Cleared decision on April 27, 1988, 63 days after receiving the submission on February 24, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.3800.

Submission Details

510(k) Number K880745 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1988
Decision Date April 27, 1988
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KPA — Slide Stainer, Automated
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3800