DeviceClearance

ELECSYS CALCHECK CA 125II— 510(k) K981278

Substantially Equivalent

Roche Diagnostics GmbH

FDA 510(k) clearance K981278 for ELECSYS CALCHECK CA 125II, Substantially Equivalent on 1998-04-23. Applicant: Roche Diagnostics GmbH.

Clearance details

Applicant
Roche Diagnostics GmbH
Product code
Code JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pleasanton, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JJX

product code JJX
Other
2
Total
2

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.