ELECSYS T3— 510(k) K962508

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K962508 for ELECSYS T3, Substantially Equivalent on 1996-08-15. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1996-06-27
Decision date: 1996-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.