ACCESS TOTAL T4 ASSAY— 510(k) K023369
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K023369 for ACCESS TOTAL T4 ASSAY, Substantially Equivalent on 2002-12-09. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code KLI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code KLI
view allMore clearances from Beckman Coulter, Inc.
view allRecalls naming K023369
K-number listed on FDA's recall record- Z-1922-2026 — Access Total T4 Calibrator, Catalog No. 33805
- Z-1303-2024 — Access Total T4, REF 33800, IVD, thyroxine reagent assay.
- Z-0613-2013 — Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023369.
Data sourced from openFDA. This site is unofficial and independent of the FDA.