IGM FLEX REAGENT CARTRIDGE
FDA 510(k) clearance K990553 · decided 1999-03-22
Clearance details
- K-number
- K990553
- Device name
- IGM FLEX REAGENT CARTRIDGE
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-22
- Decision date
- 1999-03-22
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- CFQ
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Newark, DE, 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 |
|---|---|---|
| IGA MININEPH ANTISERUM (K981786) | The Binding Site, Ltd. | 1999-11-24 |
| IMMUNOGLOBULIN A TEST SYSTEM (K990552) | Dade Behring, Inc. | 1999-03-25 |
| IGG FLEX REAGENT CARTRIDGE (K990551) | Dade Behring, Inc. | 1999-03-25 |
| OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT (K951055) | Olympus America, Inc. | 1995-04-17 |
| OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT (K951013) | Olympus America, Inc. | 1995-04-17 |
| OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT (K950900) | Olympus America, Inc. | 1995-03-27 |
| TITAN GEL IFE TRIVALENT ANTISERUM (K891188) | Helena Laboratories | 1989-03-22 |
| SPQ(TM) ANTIBODY REAGENT SET II FOR IGM (K890561) | Atlantic Antibodies | 1989-02-23 |
| MONOCLONAL RADIAL IMMUNODIFFUSION KIT (K881928) | The Binding Site, Ltd. | 1988-07-08 |
| IMMUNOGLOBULIN A TEST SYSTEM (K881827) | The Binding Site, Ltd. | 1988-06-10 |
| IMMUNOGLOBULIN M TEST SYSTEM (K881828) | The Binding Site, Ltd. | 1988-06-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003) | Dade Behring, Inc. | 2002-07-24 |
| COBAS INTEGRA CYCLOSPORINE (P920031/S002) | Dade Behring, Inc. | 2002-02-26 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001) | Dade Behring, Inc. | 2000-08-11 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031) | Dade Behring, Inc. | 1996-10-02 |