IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X— 510(k) K874033

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K874033 for IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X, Substantially Equivalent on 1988-01-05. Applicant: Diagnostic Products Corp..

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1987-10-02
Decision date: 1988-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, 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.