Rheumatoid Factor (RF) Kit for use on SPAPLUS— 510(k) K160070
Substantially EquivalentThe Binding Site Group , Ltd.
FDA 510(k) clearance K160070 for Rheumatoid Factor (RF) Kit for use on SPAPLUS, Substantially Equivalent on 2016-12-07. Applicant: The Binding Site Group , Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site Group , Ltd.
- Product code
- Code DHR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edgbaston, GB
Recent devices under product code DHR
view all- K192727 — K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
- K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
- K182747 — EliA RF IgM Immunoassay
- K162263 — Optilite Rheumatoid Factor Kit
- K143736 — ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
More clearances from The Binding Site Group , Ltd.
view allRecalls naming K160070
K-number listed on FDA's recall record- Z-1500-2020 — Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
- Z-0553-2018 — Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160070.
Data sourced from openFDA. This site is unofficial and independent of the FDA.