RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL— 510(k) K894329

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K894329 for RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL, Substantially Equivalent on 1989-09-05. Applicant: Amersham Corp..

Clearance details

Applicant: Amersham Corp.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1989-07-14
Decision date: 1989-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

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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.