510(k) K893524
- Device
- FACTOR IX DEFICIENT PLASMA
- Applicant
- MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
- 510(k) number
- K893524
- Product code
- GJT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-06-23
- Date received
- 1989-05-08
- Regulation
- 864.7290
- Classification name
- Plasma, Coagulation Factor Deficient
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BICK, PHD
- Address
- 6020 Nicolle St., Suite D Ventura CA US 93003 93003
FDA Registration Numbers#
- 8043599
- 1835316
- 1530434
- 9710666
- 3037000637
- 1181121
- 9610806
- 3008386529
- 2245451
- 2431530
- 1928890
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GJT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | 2023-09-13 |
| K180486 | HemosIL Factor XII Deficient Plasma | Instrumentation Laboratory CO | 2018-03-22 |
| K102851 | NOFACT VIII | R2 Diagnostics, Inc. | 2011-12-19 |
| K102908 | NOFACT IX | R2 Diagnostics, Inc. | 2011-12-19 |
| K110237 | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2011-07-08 |
| K050661 | HEMOSIL FACTOR II DEFICIENT PLASMA | Instrumentation Laboratory CO | 2005-05-02 |
| K043459 | HEMOSIL FACTOR XII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2005-02-09 |
| K040362 | DIAPHARMA FACTOR X KIT | Diapharma Group, Inc. | 2004-07-12 |
| K034007 | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2004-02-13 |
| K031829 | HEMOSIL FACTOR IX DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-07-31 |
| K031122 | HEMOSIL FACTOR X DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-05-19 |
| K030287 | HEMOSIL FACTOR XI DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-03-19 |
| K024082 | HEMOSIL FACTOR VII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-02-12 |
| K023839 | HEMOSIL FACTOR V DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-01-14 |
| K990814 | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 | Precision Biologic | 1999-06-07 |
Legacy Summary#
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FDA Review#
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