ST AIA-PACK TESTOSTERONE ASSAY— 510(k) K023091
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K023091 for ST AIA-PACK TESTOSTERONE ASSAY, Substantially Equivalent on 2002-12-17. Applicant: Tosoh Medics, Inc.. Device class: 1.
Clearance details
- Applicant
- Tosoh Medics, Inc.
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, CA, US
Recent devices under product code CDZ
view allMore clearances from Tosoh Medics, Inc.
view allRecalls naming K023091
K-number listed on FDA's recall record- Z-2746-2026 — ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
- Z-0674-2019 — ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
- Z-2093-2018 — ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023091.
Data sourced from openFDA. This site is unofficial and independent of the FDA.