Sickle Cell Stat A/S Heterozygous-Eryth
FDA 510(k) K842440 · Anco Medical Reagents & Assoc.
510(k) numberK842440
Submission
- Device name
- Sickle Cell Stat A/S Heterozygous-Eryth
- Applicant
- Anco Medical Reagents & Assoc.
Mchenry, IL, US - Received
- June 21, 1984
- Decision date
- July 27, 1984
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K831871 | Sickle-Heme A/S Controls & A/A ControlGHM · Traditional | 07/28/1983SE |
| K821658 | Hemoglobin ReagentKHG · Traditional | 06/25/1982SE |
| K821526 | Acid Phosphatase Reagent SetCKE · Traditional | 06/10/1982SE |
| K821102 | Megnesium Reagent KitJGJ · Traditional | 05/05/1982SE |
| K820951 | Enzymatic Cholesterol KitCHH · Traditional | 04/26/1982SE |
| K820500 | Total Lipid Reagent SetCFD · Traditional | 03/11/1982SE |
| K820491 | SGPT Reagent SetCKD · Traditional | 03/11/1982SE |
| K820466 | Sgot Reagent SetCIQ · Traditional | 03/11/1982SE |
| K812837 | Alkaline Phosphatase Reagent SetCJL · Traditional | 01/29/1982SE |
| K813415 | Urea Nitrogen Reagent SetCDW · Traditional | 12/31/1981SE |
Questions and answers
When was Sickle Cell Stat A/S Heterozygous-Eryth cleared by the FDA?
Sickle Cell Stat A/S Heterozygous-Eryth (K842440) received a 510(k) decision of Substantially Equivalent on July 27, 1984, 36 days after the submission was received.
What is the product code of K842440?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.