COAGULATION FACTOR V DEFICIENT PLASMA
FDA 510(k) clearance K981709 · decided 1998-10-13
Clearance details
- K-number
- K981709
- Device name
- COAGULATION FACTOR V DEFICIENT PLASMA
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-04
- Decision date
- 1998-10-13
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- GJT
- Device class
- 2
- Regulation number
- 864.7290
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dade Behring
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CRYOcheck Factor VIII Deficient Plasma with VWF (K222831) | Precision Biologic, Inc. | 2023-09-13 |
| HemosIL Factor XII Deficient Plasma (K180486) | Instrumentation Laboratory CO | 2018-03-22 |
| NOFACT IX (K102908) | R2 Diagnostics, Inc. | 2011-12-19 |
| NOFACT VIII (K102851) | R2 Diagnostics, Inc. | 2011-12-19 |
| HEMOSIL FACTOR VIII DEFICIENT PLASMA (K110237) | Instrumentation Laboratory CO | 2011-07-08 |
| HEMOSIL FACTOR II DEFICIENT PLASMA (K050661) | Instrumentation Laboratory CO | 2005-05-02 |
| HEMOSIL FACTOR XII DEFICIENT PLASMA (K043459) | Instrumentation Laboratory CO | 2005-02-09 |
| DIAPHARMA FACTOR X KIT (K040362) | Diapharma Group, Inc. | 2004-07-12 |
| HEMOSIL FACTOR VIII DEFICIENT PLASMA (K034007) | Instrumentation Laboratory CO | 2004-02-13 |
| HEMOSIL FACTOR IX DEFICIENT PLASMA (K031829) | Instrumentation Laboratory CO | 2003-07-31 |
| HEMOSIL FACTOR X DEFICIENT PLASMA (K031122) | Instrumentation Laboratory CO | 2003-05-19 |
| HEMOSIL FACTOR XI DEFICIENT PLASMA (K030287) | Instrumentation Laboratory CO | 2003-03-19 |
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 |