CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
FDA 510(k) clearance K924396 · decided 1993-05-21
Clearance details
- K-number
- K924396
- Device name
- CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-31
- Decision date
- 1993-05-21
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- GJT
- Device class
- 2
- Regulation number
- 864.7290
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent f recall (Z-1713-2015) | Siemens Healthcare Diagnostics, Inc. | 2015-06-05 |
| Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test recall (Z-1374-05) | Dade Behring , Inc. | 2005-08-16 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |