BAYER RAPIDLAB 1200 SYSTEM— 510(k) K031560

Substantially Equivalent

Bayer Healthcare, LLC

FDA 510(k) clearance K031560 for BAYER RAPIDLAB 1200 SYSTEM, Substantially Equivalent on 2003-12-17. Applicant: Bayer Healthcare, LLC.

Clearance details

Applicant: Bayer Healthcare, LLC
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 2003-05-19
Decision date: 2003-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.