Cleared Traditional

HISTOMATIC SLIDE STAINER, CODE-ON VERSION

K872916 · Fisher Scientific Co., LLC · Hematology
Sep 1987
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K872916 is an FDA 510(k) clearance for the HISTOMATIC SLIDE STAINER, CODE-ON VERSION, a Slide Stainer, Automated (Class I — General Controls, product code KPA), submitted by Fisher Scientific Co., LLC (Indiana, US). The FDA issued a Cleared decision on September 14, 1987, 52 days after receiving the submission on July 24, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.3800.

Submission Details

510(k) Number K872916 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1987
Decision Date September 14, 1987
Days to Decision 52 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