ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM— 510(k) K853717

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K853717 for ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM, Substantially Equivalent on 1985-10-02. Applicant: Nichols Institute Diagnostics.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1985-09-05
Decision date: 1985-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, 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.