Ortho* Hematology Control 8 Normal
FDA 510(k) K820400 · Ortho Diagnostic Systems, Inc.
510(k) numberK820400
Submission
- Device name
- Ortho* Hematology Control 8 Normal
- Applicant
- Ortho Diagnostic Systems, Inc.
Carpinteria, CA, 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
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| 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 |
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| K951100 | Ortho-Mune Ok-Combo CD3-FITC/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
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| K950482 | Ortho-Mune Ok-Comvo CD3-FITC/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/10/1996SE |
| K935720 | Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry SystemGKZ · Traditional | 05/09/1996SE |
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Questions and answers
When was Ortho* Hematology Control 8 Normal cleared by the FDA?
Ortho* Hematology Control 8 Normal (K820400) 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 K820400?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.