AIA-PACK TPOAB ASSAY— 510(k) K981521

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K981521 for AIA-PACK TPOAB ASSAY, Substantially Equivalent on 1998-10-08. Applicant: Tosoh Medics, Inc.. Device class: 2.

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1998-04-28
Decision date: 1998-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K981521

K-number listed on FDA's recall record

Z-2827-2018 — Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.Class III·Terminated·Tosoh Bioscience Inc·20180605
Z-2168-2017 — AIA-PACK TPOAb CONTROL SETClass III·Terminated·Tosoh Bioscience, Inc.·20170208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981521.

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