ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM— 510(k) K872390

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K872390 for ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM, Substantially Equivalent on 1987-09-02. Applicant: Nichols Institute Diagnostics.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1987-06-19
Decision date: 1987-09-02
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.