DeviceClearance

K983892

Substantially Equivalent

COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P

Applicant
Roche Diagnostics/Boehringer Mannheim GmbH
Product code
JPA
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JPA

product code JPA
Death
6
Total
6

Source: openFDA MAUDE database, through . 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.