Tri-Count
FDA 510(k) K851375 · Hematology Marketing Assoc.
510(k) numberK851375
Submission
- Device name
- Tri-Count
- Applicant
- Hematology Marketing Assoc.
Concord, CA, US - Received
- April 8, 1985
- Decision date
- July 12, 1985
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K851843 | Osmocel 3GIF · Traditional | 07/30/1985SE |
| K850097 | Laser-LyseGGK · Traditional | 03/29/1985SE |
| K850096 | Laser-GlobinGKR · Traditional | 03/29/1985SE |
| K850095 | Laser-DilGIF · Traditional | 03/29/1985SE |
| K850094 | Laser-Globin PowderGKR · Traditional | 03/29/1985SE |
| K844708 | Tri-Count CalibratorKSA · Traditional | 03/05/1985SE |
| K843485 | Tri-Count LaserJPK · Traditional | 12/12/1984SE |
| K834371 | Tri-Count 10JPK · Traditional | 03/09/1984SE |
| K833130 | Tri-Count 7JPK · Traditional | 10/20/1983SE |
| K831306 | HemacalKRZ · Traditional | 06/16/1983SE |
Questions and answers
When was Tri-Count cleared by the FDA?
Tri-Count (K851375) received a 510(k) decision of Substantially Equivalent on July 12, 1985, 95 days after the submission was received.
What is the product code of K851375?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.