CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
FDA 510(k) clearance K990296 · decided 1999-03-18
Clearance details
- K-number
- K990296
- Device name
- CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
- Applicant
- Precision Biologic
- Decision
- Substantially Equivalent
- Date received
- 1999-01-28
- Decision date
- 1999-03-18
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- GJT
- Device class
- 2
- Regulation number
- 864.7290
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Dartmouth, N.S., CA
- Third-party review
- No
- Expedited review
- No
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| 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.