HISTOMATIC SLIDE STAINER, CODE-ON VERSION— 510(k) K872916

Name: FDA 510(k) clearance K872916
Creator: U.S. Food and Drug Administration
Published: 1987-09-14

Substantially Equivalent

Fisher Scientific Co., LLC

FDA 510(k) clearance K872916 for HISTOMATIC SLIDE STAINER, CODE-ON VERSION, Substantially Equivalent on 1987-09-14. Applicant: Fisher Scientific Co., LLC. Device class: 1.

Clearance details

Applicant: Fisher Scientific Co., LLC
Product code: Code KPA
Device class: Class 1
Regulation: 21 CFR 864.3800
Advisory panel: Pathology
Date received: 1987-07-24
Decision date: 1987-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indiana, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPA

product code KPA

Malfunction: 1,177
Total: 1,177

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.