TISSUE-TEK III MINI-RAPID PROCESSOR— 510(k) K801427

Name: FDA 510(k) clearance K801427
Creator: U.S. Food and Drug Administration
Published: 1980-07-28

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K801427 for TISSUE-TEK III MINI-RAPID PROCESSOR, Substantially Equivalent on 1980-07-28. Applicant: Miles Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code IEO
Device class: Class 1
Regulation: 21 CFR 864.3875
Advisory panel: Pathology
Date received: 1980-06-17
Decision date: 1980-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IEO

product code IEO

Injury: 326
Total: 326

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.