NOFACT IX
FDA 510(k) clearance K102908 · decided 2011-12-19
Clearance details
- K-number
- K102908
- Device name
- NOFACT IX
- Applicant
- R2 Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-01
- Decision date
- 2011-12-19
- Days to decision
- 444 days
- Clearance type
- Traditional
- Product code
- GJT
- Device class
- 2
- Regulation number
- 864.7290
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- South Bend, IN, 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 |
|---|---|---|
| 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 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 |
| HEMOSIL FACTOR VII DEFICIENT PLASMA (K024082) | Instrumentation Laboratory CO | 2003-02-12 |
Recalls involving this device
No recalls on record reference this clearance.