REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
FDA 510(k) clearance K031208 · decided 2003-07-07
Clearance details
- K-number
- K031208
- Device name
- REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
- Applicant
- Corgenix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-17
- Decision date
- 2003-07-07
- Days to decision
- 81 days
- Clearance type
- Special
- Product code
- MSV
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Westminster, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Aptiva APS IgA Reagent (K243979) | Inova Diagnostics, Inc. | 2026-02-06 |
| EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (K181329) | Phadia AB | 2018-06-25 |
| 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 (K162788) | Immco Diagnostics, Inc. | 2017-06-19 |
| QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls (K152875) | Inova Diagnostics, Inc. | 2015-12-21 |
| QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. (K141274) | Inova Diagnostics, Inc. | 2015-02-13 |
| ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY (K112414) | Phadia US, Inc. | 2012-06-22 |
| HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS (K091556) | Instrumentation Laboratory CO | 2010-05-21 |
| THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR (K092757) | Thera-Test Laboratories, Inc. | 2009-10-09 |
| IGG ANTI-ATHEROX TEST KIT (K072032) | Corgenix, Inc. | 2008-04-04 |
| AESKULSKA BETA2-GLYCO-A (K062217) | Aesku, Inc. | 2006-12-13 |
| VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 (K040451) | Pharmacia Deutschland GmbH | 2004-05-11 |
| VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 (K040449) | Pharmacia Deutschland GmbH | 2004-05-11 |
Recalls involving this device
No recalls on record reference this clearance.