Ortho* Hematology Contr. 8 Abn. Hi/Low
FDA 510(k) K820401 · Orhto Diagnostic Systems, Inc.
510(k) numberK820401
Submission
- Device name
- Ortho* Hematology Contr. 8 Abn. Hi/Low
- Applicant
- Orhto Diagnostic Systems, Inc.
Mchenry, IL, US - Received
- February 12, 1982
- Decision date
- March 15, 1982
- 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 |
Questions and answers
When was Ortho* Hematology Contr. 8 Abn. Hi/Low cleared by the FDA?
Ortho* Hematology Contr. 8 Abn. Hi/Low (K820401) received a 510(k) decision of Substantially Equivalent on March 15, 1982, 31 days after the submission was received.
What is the product code of K820401?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.