BAYER RAPIDPOINT 400 SYSTEM— 510(k) K002738

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K002738 for BAYER RAPIDPOINT 400 SYSTEM, Substantially Equivalent on 2000-12-19. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 2000-09-01
Decision date: 2000-12-19
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.