HEMA-TEK II SLIDE STAINER— 510(k) K771559

Name: FDA 510(k) clearance K771559
Creator: U.S. Food and Drug Administration
Published: 1977-08-25

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K771559 for HEMA-TEK II SLIDE STAINER, Substantially Equivalent on 1977-08-25. Applicant: Miles Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code KPA
Device class: Class 1
Regulation: 21 CFR 864.3800
Advisory panel: Pathology
Date received: 1977-08-15
Decision date: 1977-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.