Quanticel HHR + Two Human Hematology W/Platelets
FDA 510(k) K844927 · Bhp Diagnostix, Inc.
510(k) numberK844927
Submission
- Device name
- Quanticel HHR + Two Human Hematology W/Platelets
- Applicant
- Bhp Diagnostix, Inc.
West Chester, PA, US - Received
- December 19, 1984
- Decision date
- March 22, 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 |
|---|---|---|
| K904503 | Seracon CR ReferenceJJX · Traditional | 11/02/1990SE |
| K863648 | Seracon CT ReferenceJJY · Traditional | 10/29/1986SE |
| K862594 | Seracon(Tm) Cal (Product No. DO35)JIX · Traditional | 08/19/1986SE |
| K844928 | Quanticel HHR Two Human Hematology ReferenceJPK · Traditional | 03/22/1985SE |
| K844027 | Seracon TM SR IIIJIX · Traditional | 11/27/1984SE |
| K844026 | Seracon TM SR IVJIX · Traditional | 11/27/1984SE |
| K792487 | Seracon-SriiJIX · Traditional | 12/31/1979SE |
| K792486 | Seracon-Sri (Prod. # D029JIX · Traditional | 12/31/1979SE |
| K792485 | Seracon-SriJIX · Traditional | 12/31/1979SE |
| K791958 | Seracon - El DO27JJY · Traditional | 10/17/1979SE |
Questions and answers
When was Quanticel HHR + Two Human Hematology W/Platelets cleared by the FDA?
Quanticel HHR + Two Human Hematology W/Platelets (K844927) received a 510(k) decision of Substantially Equivalent on March 22, 1985, 93 days after the submission was received.
What is the product code of K844927?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.