Sandare Lyophilized Hemoglobin Controls
FDA 510(k) K800780 · Sandare Chemical Co., Inc.
510(k) numberK800780
Submission
- Device name
- Sandare Lyophilized Hemoglobin Controls
- Applicant
- Sandare Chemical Co., Inc.
Walker, MI, US - Received
- April 8, 1980
- Decision date
- April 24, 1980
- 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 |
|---|---|---|
| K872852 | Eagle Diagnostics Glycohemoglobin Unitized TestLCP · Traditional | 09/29/1987SE |
| K862556 | Sandare Glycohemoglobin ProcedureLCP · Traditional | 08/08/1986SE |
| K860684 | Sandare BCG Albumin ProcedureCIX · Traditional | 03/17/1986SE |
| K851395 | Sandare Iron-Binding Capacity ProcedureJMO · Traditional | 05/07/1985SE |
| K851394 | Sandare Iron ProcedureJIY · Traditional | 04/30/1985SE |
| K844498 | Sandare Alkaline Phosphatase ProcedureCIO · Traditional | 12/10/1984SE |
| K842516 | Sandare Acid Phosphatase ProcedureCJR · Traditional | 08/17/1984SE |
| K833898 | Tri-Level Bilirubin ControlsJJX · Traditional | 01/13/1984SE |
| K832942 | Total & Direct Bilirubin ProceduresCIG · Traditional | 11/07/1983SE |
| K832632 | Albumin Procedure BCPCJW · Traditional | 09/12/1983SE |
Questions and answers
When was Sandare Lyophilized Hemoglobin Controls cleared by the FDA?
Sandare Lyophilized Hemoglobin Controls (K800780) received a 510(k) decision of Substantially Equivalent on April 24, 1980, 16 days after the submission was received.
What is the product code of K800780?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.