ST AIA-PACK CA 19-9— 510(k) K023240

Name: FDA 510(k) clearance K023240
Creator: U.S. Food and Drug Administration
Published: 2002-12-23

Substantially Equivalent

Tosoh Corp.

FDA 510(k) clearance K023240 for ST 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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K100375 — DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC6042011-04-06

More clearances from Tosoh Corp.

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K023239 — AIA-PACK CA 19-92002-12-23
K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM1992-07-21
K913663 — AIA-PACK T-U1991-09-30
K913298 — AIA-PACK CK-MB1991-09-27
K913493 — AIA-PACK FT41991-09-10

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 →

Recalls naming K023240

K-number listed on FDA's recall record

Z-2069-2018 — ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor MarkerClass II·Terminated·Tosoh Bioscience Inc·20180305

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023240.

Data sourced from openFDA. This site is unofficial and independent of the FDA.