Normal Hematology Control Unassayed
FDA 510(k) K781572 · Ortho Diagnostics, Inc.
510(k) numberK781572
Submission
- Device name
- Normal Hematology Control Unassayed
- Applicant
- Ortho Diagnostics, Inc.
Mchenry, IL, US - Received
- September 14, 1978
- Decision date
- October 17, 1978
- 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 |
|---|---|---|
| K802404 | Ortho Bovine Albumin Solution 30% ProteDCF · Traditional | 10/23/1980SE |
| K801507 | Antigen Control CellsGOL · Traditional | 08/20/1980SE |
| K800357 | Bi-Level Assayed Card. Drug Cont., I,IiLAS · Traditional | 04/16/1980SE |
| K800310 | Ortho Antisera ControlKSF · Traditional | 03/05/1980SE |
| K791791 | Ortho Antibody Enhancement SolutionKSG · Traditional | 10/11/1979SE |
| K791301 | Ortho TSH Ria KitJLW · Traditional | 09/24/1979SE |
| K790813 | Multecon Blood Gas ControlJJS · Traditional | 06/28/1979SE |
| K782166 | Slide Test for Pregnancy, Gravindex 90JHJ · Traditional | 04/04/1979SE |
| K782063 | Pregnancy, Sensidex Tube TestJHJ · Traditional | 04/04/1979SE |
| K781638 | Rubindex*Direct SystemGOK · Traditional | 12/20/1978SE |
Questions and answers
When was Normal Hematology Control Unassayed cleared by the FDA?
Normal Hematology Control Unassayed (K781572) received a 510(k) decision of Substantially Equivalent on October 17, 1978, 33 days after the submission was received.
What is the product code of K781572?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.