Acid Phosphatase Reagent Set
FDA 510(k) K821526 · Anco Medical Reagents & Assoc.
510(k) numberK821526
Submission
- Device name
- Acid Phosphatase Reagent Set
- Applicant
- Anco Medical Reagents & Assoc.
Mchenry, IL, US - Received
- May 21, 1982
- Decision date
- June 10, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CKE – Acid Phosphatase, Thymolphthale Inmonophosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1020
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CKE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914167 | Clinical Chem.Anal.Acid,Prostatic Acid PhosphataseCKE · Traditional | Eastman Kodak Company | 03/17/1992SE |
| K915705 | Acid Phosphatase Reagent SetCKE · Traditional | Tech Intl. Co. | 02/27/1992SE |
| K873726 | Acid Phosphatase TestCKE · Traditional | King Diagnostics, Inc. | 01/27/1988SE |
| K864230 | Dimension (TM) Clinical Chemistry SystemCKE · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 11/28/1986SE |
| K860476 | Acid Phosphatase Reagent SetCKE · Traditional | Sterling Diagnostics, Inc. | 03/05/1986SE |
| K843380 | Acid Phosphatase Assay KitCKE · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 09/20/1984SE |
| K800693 | Stanbio Prostatic Acid Phosphatase TestCKE · Traditional | Stanbio Laboratory | 04/16/1980SE |
| K790524 | Data-Zyme Acia Phosphatase ProcedureCKE · Traditional | Data Medical Associates, Inc. | 05/23/1979SE |
More from Data Medical Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842440 | Sickle Cell Stat A/S Heterozygous-ErythJPK · Traditional | 07/27/1984SE |
| K831871 | Sickle-Heme A/S Controls & A/A ControlGHM · Traditional | 07/28/1983SE |
| K821658 | Hemoglobin ReagentKHG · Traditional | 06/25/1982SE |
| 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 Acid Phosphatase Reagent Set cleared by the FDA?
Acid Phosphatase Reagent Set (K821526) received a 510(k) decision of Substantially Equivalent on June 10, 1982, 20 days after the submission was received.
What is the product code of K821526?
The FDA product code is CKE – Acid Phosphatase, Thymolphthale Inmonophosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.