Data-Zyme Acia Phosphatase Procedure
FDA 510(k) K790524 · Data Medical Associates, Inc.
510(k) numberK790524
Submission
- Device name
- Data-Zyme Acia Phosphatase Procedure
- Applicant
- Data Medical Associates, Inc.
Mchenry, IL, US - Received
- March 15, 1979
- Decision date
- May 23, 1979
- 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 |
| K821526 | Acid Phosphatase Reagent SetCKE · Traditional | Anco Medical Reagents & Assoc. | 06/10/1982SE |
| K800693 | Stanbio Prostatic Acid Phosphatase TestCKE · Traditional | Stanbio Laboratory | 04/16/1980SE |
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| K971113 | Dma Triglycerides ProceduresCDT · Traditional | 05/29/1997SE |
| K961919 | Dma Gamma Glutamyltransferase (GGT) ProcedureJPZ · Traditional | 07/01/1996SE |
| K955796 | Iron Calibrator & Calibration Verification SetJJX · Traditional | 02/29/1996SE |
| K955302 | Serum Bicarbonate/Carbon DioxideKHS · Traditional | 02/29/1996SE |
| K955300 | Total Bilirubin ProcedureCIG · Traditional | 12/20/1995SE |
| K952437 | Dma Glucose Hexokinase U.V. ProcedureCFR · Traditional | 10/03/1995SE |
| K946161 | Dma Total Cholesterol ProcedureCHH · Traditional | 08/23/1995SE |
| K946354 | Dma Unsaturated Iron Binding Capacity ProcedureJMO · Traditional | 05/08/1995SE |
| K946355 | Dma Albumin ProcedureCIX · Traditional | 03/01/1995SE |
Questions and answers
When was Data-Zyme Acia Phosphatase Procedure cleared by the FDA?
Data-Zyme Acia Phosphatase Procedure (K790524) received a 510(k) decision of Substantially Equivalent on May 23, 1979, 69 days after the submission was received.
What is the product code of K790524?
The FDA product code is CKE – Acid Phosphatase, Thymolphthale Inmonophosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.