FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
K Number: K982879
·
Decision Oct 15, 1998
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
45
Applicant Total
27
Review Days
62
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
- K Number
- K982879
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shield Diagnostics, Ltd.
- Date Received
- August 14, 1998
- Decision Date
- October 15, 1998
- Product Code
- MSV
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSV), ordered by most recent decision date.
Aptiva APS IgA Reagent
FDA 510(k)
FDA Class 2
·Immunology
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
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
FDA 510(k)
FDA Class 2
·Immunology
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
FDA 510(k)
FDA Class 2
·Immunology
QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
FDA 510(k)
FDA Class 2
·Immunology
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Shield Diagnostics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K000398 | SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 | Apr 17, 2000 | Substantially Equivalent |
| K980885 | SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY | Aug 21, 1998 | Substantially Equivalent |
| K972981 | SHIELD HELICO-G2 ELISA KIT | Mar 17, 1998 | Substantially Equivalent |
| K962825 | SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY | Nov 15, 1996 | Substantially Equivalent |
| K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | Nov 7, 1996 | Substantially Equivalent |
| K961515 | QUANTASE PHENYLALANINE ASSAY | Jun 12, 1996 | Substantially Equivalent |
| K955303 | DIASTAT ANTI-CARDIOLIPIN KIT | May 30, 1996 | Substantially Equivalent |
| K952183 | DIASTAT ANTI-THYROGLOBULIN KIT | Jun 30, 1995 | Substantially Equivalent |
| K951487 | DIASTAT ANTI-THYROID PEROXIDASE KIT | Jun 30, 1995 | Substantially Equivalent |
| K943630 | DIASTAT ANTI-MPO (PANCA) KIT | Mar 6, 1995 | Substantially Equivalent |