AIA-PACK IGE CALIBRATION VERIFICATION TEST SET— 510(k) K924859

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K924859 for AIA-PACK IGE CALIBRATION VERIFICATION TEST SET, Substantially Equivalent on 1993-05-14. Applicant: Tosoh Medics, Inc..

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1992-09-28
Decision date: 1993-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.