AIA-PACK CA 19-9— 510(k) K023239

Name: FDA 510(k) clearance K023239
Creator: U.S. Food and Drug Administration
Published: 2002-12-23

Substantially Equivalent

Tosoh Corp.

FDA 510(k) clearance K023239 for AIA-PACK CA 19-9, Substantially Equivalent on 2002-12-23. Applicant: Tosoh Corp.. Device class: 2.

Clearance details

Applicant: Tosoh Corp.
Product code: Code NIG
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2002-09-27
Decision date: 2002-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seymour, CT, US

Download summary PDF View on FDA.gov ↗

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K023240 — ST AIA-PACK CA 19-92002-12-23
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K913663 — AIA-PACK T-U1991-09-30
K913298 — AIA-PACK CK-MB1991-09-27
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Adverse events under product code NIG

product code NIG

Malfunction: 618
Total: 618

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.