CONTREX PLUS LOW CONTROL SOLUTION— 510(k) K100747

Substantially Equivalent

Apex BioTechnology Corp.

FDA 510(k) clearance K100747 for CONTREX PLUS LOW CONTROL SOLUTION, Substantially Equivalent on 2010-04-14. Applicant: Apex BioTechnology Corp..

Clearance details

Applicant: Apex BioTechnology Corp.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2010-03-16
Decision date: 2010-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.