MIDAS II AUTOMATIC STAINER— 510(k) K842077

Name: FDA 510(k) clearance K842077
Creator: U.S. Food and Drug Administration
Published: 1984-07-27

Substantially Equivalent

Innovative Medical Systems, Inc.

FDA 510(k) clearance K842077 for MIDAS II AUTOMATIC STAINER, Substantially Equivalent on 1984-07-27. Applicant: Innovative Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Innovative Medical Systems, Inc.
Product code: Code KPA
Device class: Class 1
Regulation: 21 CFR 864.3800
Advisory panel: Pathology
Date received: 1984-05-23
Decision date: 1984-07-27
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 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.