CYBERFLUOR 615 IMMUNOANALYZER— 510(k) K872803

Name: FDA 510(k) clearance K872803
Creator: U.S. Food and Drug Administration
Published: 1987-09-02

Substantially Equivalent

Cyberfluor, Inc.

FDA 510(k) clearance K872803 for CYBERFLUOR 615 IMMUNOANALYZER, Substantially Equivalent on 1987-09-02. Applicant: Cyberfluor, Inc.. Device class: 1.

Clearance details

Applicant: Cyberfluor, Inc.
Product code: Code KHO
Device class: Class 1
Regulation: 21 CFR 862.2560
Advisory panel: Clinical Chemistry
Date received: 1987-07-15
Decision date: 1987-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario M5t 1x4, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KHO

product code KHO

Malfunction: 1,339
Total: 1,339

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.