EL-B2GP1SCR— 510(k) K973882
Substantially EquivalentTheratest Laboratories, Inc.
FDA 510(k) clearance K973882 for EL-B2GP1SCR, Substantially Equivalent on 1997-12-05. Applicant: Theratest Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Theratest Laboratories, Inc.
- 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
- Chicago, IL, US
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 Theratest Laboratories, Inc.
view all- K090753 — THERATEST EL-ANTI-CCP/2
- K090760 — THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
- K071692 — THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
- K061376 — EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
- K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
Data sourced from openFDA. This site is unofficial and independent of the FDA.