Diatech, Inc.
Medical device manufacturer in Fort Lauderdale, FL.
17510(k) clearances
0PMA approvals
0recalls
Device types
- JPA System, Multipurpose For In Vitro… 5
- GGP Test, Qualitative And Quantitative Factor… 3
- KQJ System, Fibrinogen Determination 2
- GGN Plasma, Coagulation Control 1
- GGW Test, Time, Partial Thromboplastin 1
- GJS Test, Time, Prothrombin 1
- GIR Reagent, Russel Viper Venom 1
- JPK Mixture, Hematology Quality Control 1
- GIS Test, Fibrinogen 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K881685 | Fibrinogentest-OGIS · Traditional | 08/09/1988SE |
| K854938 | Coascreener/Diascreenerblood Plasma Timing Inst.JPA · Traditional | 03/12/1986SE |
| K854090 | DIATIMER-2 Blood Plasma Clot Timing InstrumentJPA · Traditional | 01/06/1986SE |
| K854089 | DIATIMER-1 Blood Plasma Clot Timing InstrumentJPA · Traditional | 01/06/1986SE |
| K842286 | Dia T1, T2 & T3JPK · Traditional | 09/11/1984SE |
| K841523 | Owren's Veronal BufferrJPA · Traditional | 06/01/1984SE |
| K841462 | Heparin Coagulation Control Plasma 1-JPA · Traditional | 06/01/1984SE |
| K841366 | Dia FibrinKQJ · Traditional | 06/01/1984SE |
| K841365 | Dia ReptinGIR · Traditional | 06/01/1984SE |
| K841461 | Coagulation Control Plasma Level 1/2/3GGP · Traditional | 05/02/1984SE |
| K840802 | Dia Thrombin Dia PlastinGJS · Traditional | 05/01/1984SE |
| K841522 | Calcium ChlorideGGW · Traditional | 04/30/1984SE |
| K840928 | Factor Deficient Substrate Plasma ViiiGGP · Traditional | 04/30/1984SE |
| K840927 | Factor Deficient Substrate Plasma IIGGP · Traditional | 04/30/1984SE |
| K840801 | Dia-H 1/2/3 & Dia-Ht 1/2/3 · Traditional | 04/25/1984SE |
| K840288 | DiacelinGGN · Traditional | 04/23/1984SE |
| K834571 | Fibrinogen TestKQJ · Traditional | 02/04/1984SE |