ELECSYS FT4 ASSAY— 510(k) K961489

Name: FDA 510(k) clearance K961489
Creator: U.S. Food and Drug Administration
Published: 1996-06-11

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K961489 for ELECSYS FT4 ASSAY, Substantially Equivalent on 1996-06-11. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CEC
Device class: Class 2
Regulation: 21 CFR 862.1695
Advisory panel: Clinical Chemistry
Date received: 1996-04-18
Decision date: 1996-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.