ELSA-PTH— 510(k) K950211

Name: FDA 510(k) clearance K950211
Creator: U.S. Food and Drug Administration
Published: 1995-04-13

Substantially Equivalent

Cis-Us, Inc.

FDA 510(k) clearance K950211 for ELSA-PTH, Substantially Equivalent on 1995-04-13. Applicant: Cis-Us, Inc.. Device class: 2.

Clearance details

Applicant: Cis-Us, Inc.
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
Advisory panel: Clinical Chemistry
Date received: 1995-01-19
Decision date: 1995-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

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.