DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT— 510(k) K042448

Substantially Equivalent

General Atomics

FDA 510(k) clearance K042448 for DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT, Substantially Equivalent on 2004-10-29. Applicant: General Atomics.

Clearance details

Applicant: General Atomics
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2004-09-09
Decision date: 2004-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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.