AIA-PACK TGAB ASSAY— 510(k) K981522
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K981522 for AIA-PACK TGAB 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster City, CA, US
Recent devices under product code JZO
view allMore clearances from Tosoh Medics, Inc.
view allRecalls naming K981522
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.
- Z-2169-2017 — AIA-PACK TgAb CONTROL SET
- Z-1187-2021 — Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981522.
Data sourced from openFDA. This site is unofficial and independent of the FDA.