DIASTAT ANTI-CARDIOLIPIN KIT
FDA 510(k) clearance K921265 · decided 1992-08-03
Clearance details
- K-number
- K921265
- Device name
- DIASTAT ANTI-CARDIOLIPIN KIT
- Applicant
- Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-16
- Decision date
- 1992-08-03
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- MID
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Dundee, GB
- 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 IgG Reagent; Aptiva APS IgM Reagent (K223093) | Inova Diagnostics, Inc. | 2024-12-17 |
| ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY (K131821) | Phadia US, Inc. | 2013-12-23 |
| BIOPLEX 2200 APLS IGM (K130528) | Bio-Rad Laboratories | 2013-10-21 |
| QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA (K120817) | Inova Diagnostics, Inc. | 2013-02-26 |
| IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS (K113020) | Immco Diagnostics, Inc. | 2012-10-25 |
| BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS (K103834) | Bio-Rad Laboratories | 2012-03-30 |
| ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (K102425) | Zeus Scientific, Inc. | 2011-12-12 |
| CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM (K091845) | Phadia US, Inc. | 2010-06-07 |
| HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS (K092181) | Instrumentation Laboratory CO | 2010-03-11 |
| EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (K060176) | Theratest Laboratories, Inc. | 2006-02-07 |
| AESKULISA CARDIOLIPIN AGM (K040463) | Aesku, Inc. | 2004-05-12 |
| REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 (K032868) | Corgenix, Inc. | 2003-10-14 |
Recalls involving this device
No recalls on record reference this clearance.