Dia T1, T2 & T3
FDA 510(k) K842286 · Diatech, Inc.
510(k) numberK842286
Submission
- Device name
- Dia T1, T2 & T3
- Applicant
- Diatech, Inc.
Mchenry, IL, US - Received
- June 13, 1984
- Decision date
- September 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPK – Mixture, Hematology Quality Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code JPK
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|---|---|---|---|
| K160590 | XN CheckJPK · Traditional | Streck | 12/22/2016SE |
| K160588 | XN Check BFJPK · Traditional | Streck | 12/22/2016SE |
| K160586 | Xn-L CheckJPK · Traditional | Streck | 12/22/2016SE |
| K160606 | BC-5D Hematology ControlJPK · Traditional | R&D Systems, Inc. | 09/01/2016SE |
| K141964 | XN CheckJPK · Traditional | Streck | 12/05/2014SE |
| K141957 | XN Check BFJPK · Traditional | Streck | 12/05/2014SE |
| K130962 | R&D 5D Retic Hematology ControlJPK · Special | R&D Systems, Inc. | 07/24/2013SE |
| K120744 | XN Check BFJPK · Traditional | Streck | 10/19/2012SE |
| K120742 | XN CheckJPK · Traditional | Streck | 10/19/2012SE |
| K101578 | R&D Systems Body Fluid-I Hematology ControlJPK · Traditional | R&D Systems, Inc. | 04/28/2011SE |
More from R&D Systems, Inc.
| 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 |
| 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 |
Questions and answers
When was Dia T1, T2 & T3 cleared by the FDA?
Dia T1, T2 & T3 (K842286) received a 510(k) decision of Substantially Equivalent on September 11, 1984, 90 days after the submission was received.
What is the product code of K842286?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.