AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT— 510(k) K882907

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K882907 for AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT, Substantially Equivalent on 1988-09-22. Applicant: Amersham Corp..

Clearance details

Applicant: Amersham Corp.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1988-07-12
Decision date: 1988-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

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Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.