AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM— 510(k) K971103

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K971103 for AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM, Substantially Equivalent on 1997-06-27. Applicant: Tosoh Medics, Inc..

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code KHO
Advisory panel: Clinical Chemistry
Date received: 1997-03-26
Decision date: 1997-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KHO

product code KHO

Malfunction: 1,339
Total: 1,339

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.