DADE THROMBIN REAGENT
FDA 510(k) clearance K050928 · decided 2005-06-29
Clearance details
- K-number
- K050928
- Device name
- DADE THROMBIN REAGENT
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-14
- Decision date
- 2005-06-29
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- KQJ
- Device class
- 2
- Regulation number
- 864.7340
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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|---|---|---|
| HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (K251968) | Instrumentation Laboratory (IL) Co. | 2025-07-24 |
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| SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) (K971858) | Sigma Diagnostics, Inc. | 1997-10-09 |
| FIF TM (K970189) | Panbio, Inc. | 1997-05-21 |
| N-ASSAY TIA FIBRINOGEN TEST KIT (K965113) | Crestat Diagnostics, Inc. | 1997-04-16 |
| MULTIFIBREN U (K934326) | Behring Diagnostics, Inc. | 1994-04-19 |
| IL TEST FIBRINOGEN-C (K931721) | Instrumentation Laboratory CO | 1993-08-13 |
| FIBRINOGEN RID TEST KIT (K922416) | The Binding Site, Ltd. | 1993-03-09 |
| MULTIFIBREN (K925988) | Behring Diagnostics, Inc. | 1993-03-01 |
| HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS (K923593) | International Technidyne Corp. | 1992-09-22 |
| QBC FIBRINOGEN (K920258) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-06-26 |
| SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) (K900939) | Incstar Corp. | 1990-05-16 |
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 |