RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER— 510(k) K050100

Name: FDA 510(k) clearance K050100
Creator: U.S. Food and Drug Administration
Published: 2005-02-25

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K050100 for RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER, Substantially Equivalent on 2005-02-25. Applicant: Bionostics, Inc.. Device class: 1.

Clearance details

Applicant: Bionostics, Inc.
Product code: Code JJX
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2005-01-18
Decision date: 2005-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Devens, MA, US

Download summary PDF View on FDA.gov ↗

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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.