Ez-Range
FDA 510(k) K941965 · Hematronix, Inc.
510(k) numberK941965
Submission
- Device name
- Ez-Range
- Applicant
- Hematronix, Inc.
Benicia, CA, US - Received
- April 22, 1994
- Decision date
- April 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K012243 | MCC Uricheck Assayed Liquid Urine Multiconstituent ControlJJY · Traditional | 08/20/2001SE |
| K993496 | Retic-QuinoxJPK · Traditional | 11/30/1999SE |
| K972710 | QUANTIFY(901)JJW · Traditional | 08/15/1997SE |
| K960471 | Tri-Count 20JPK · Traditional | 03/20/1996SE |
| K960005 | Tri-Court 20-TJPK · Traditional | 03/19/1996SE |
| K935343 | Centrifiq Blood ControlJPK · Traditional | 01/27/1994SE |
| K904461 | Meter TraxJPK · Traditional | 10/26/1990SE |
| K902389 | Tri-Count 16JCN · Traditional | 08/22/1990SE |
Questions and answers
When was Ez-Range cleared by the FDA?
Ez-Range (K941965) received a 510(k) decision of Substantially Equivalent on April 25, 1995, 368 days after the submission was received.
What is the product code of K941965?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.