AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT— 510(k) K881355

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K881355 for AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT, Substantially Equivalent on 1988-06-08. Applicant: Amersham Corp..

Clearance details

Applicant: Amersham Corp.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1988-04-18
Decision date: 1988-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

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Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.