SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY— 510(k) K982879
Substantially EquivalentShield Diagnostics, Ltd.
FDA 510(k) clearance K982879 for SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY, Substantially Equivalent on 1998-10-15. Applicant: Shield Diagnostics, Ltd.. Device class: 2.
Clearance details
- Applicant
- Shield Diagnostics, Ltd.
- Product code
- Code MSV
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee, GB
Recent devices under product code MSV
view all- K243979 — Aptiva APS IgA Reagent
- K181329 — EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
- K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
- K152875 — QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
- K141274 — QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
More clearances from Shield Diagnostics, Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.