IMMULITE(TM) HCG— 510(k) K911796

Substantially Equivalent

Cirrus Diagnostics, Inc.

FDA 510(k) clearance K911796 for IMMULITE(TM) HCG, Substantially Equivalent on 1991-06-20. Applicant: Cirrus Diagnostics, Inc..

Clearance details

Applicant: Cirrus Diagnostics, Inc.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1991-04-22
Decision date: 1991-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chester, NJ, US

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Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.