Calibration Verification Assessment (Cva)
FDA 510(k) K960557 · Streck Laboratories, Inc.
510(k) numberK960557
Submission
- Device name
- Calibration Verification Assessment (Cva)
- Applicant
- Streck Laboratories, Inc.
Omaha, NE, US - Received
- February 9, 1996
- Decision date
- April 3, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K042587 | Retic-Chex for Cell-DynJPK · Traditional | 10/19/2004SE |
| K040107 | Cyto-Chex BCTJKA · Traditional | 07/27/2004SE |
| K040025 | A1C-CELLULARJJX · Traditional | 03/02/2004SE |
| K023656 | Sickle-Chex Solubility KitGHM · Traditional | 12/30/2002SE |
| K021922 | Modification to Para 5XJPK · Special | 06/25/2002SE |
| K020469 | Cal-Chex CD PlusKRX · Traditional | 04/04/2002SE |
| K013316 | Sickle-ChexGHM · Traditional | 11/06/2001SE |
| K011410 | Para 5XJPK · Traditional | 06/26/2001SE |
| K001443 | Sugar Chex OneJJX · Traditional | 06/29/2000SE |
| K000945 | Para 12 Plus ReticsGLQ · Traditional | 04/18/2000SE |
Questions and answers
When was Calibration Verification Assessment (Cva) cleared by the FDA?
Calibration Verification Assessment (Cva) (K960557) received a 510(k) decision of Substantially Equivalent on April 3, 1996, 54 days after the submission was received.
What is the product code of K960557?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.