Acid Phosphatase Test
FDA 510(k) K873726 · King Diagnostics, Inc.
510(k) numberK873726
Submission
- Device name
- Acid Phosphatase Test
- Applicant
- King Diagnostics, Inc.
Indianapolis, IN, US - Received
- September 15, 1987
- Decision date
- January 27, 1988
- 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 |
| 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 |
| K790524 | Data-Zyme Acia Phosphatase ProcedureCKE · Traditional | Data Medical Associates, Inc. | 05/23/1979SE |
More from Data Medical Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933329 | King Diagnostics Iron and Total Iron Binding Capacity ReagentJMO · Traditional | 10/22/1993SE |
| K931834 | King Sodium/Potassium Standard ModifiedJIS · Traditional | 08/25/1993SE |
| K931773 | HDL Precipitating Reagent (Dextran Sulfate)LBR · Traditional | 08/16/1993SE |
| K931326 | King Diagnostics CK ReagentCGS · Traditional | 06/15/1993SE |
| K923129 | King Diagnostics Glucose (HK) ReagentCFR · Traditional | 11/02/1992SE |
| K922969 | King Diagnostics Urea Nitrogen ReagentCDN · Traditional | 10/13/1992SE |
| K922921 | King Diagnostics Chloride ReagentCHJ · Traditional | 10/05/1992SE |
| K923927 | King Diagnostics Magnesium ReagentJGJ · Traditional | 09/30/1992SE |
| K923128 | King Diagnostics Cholesterol ReagentCHH · Traditional | 09/09/1992SE |
| K923091 | King Diagnostics Gamma GT ReagentJPZ · Traditional | 09/09/1992SE |
Questions and answers
When was Acid Phosphatase Test cleared by the FDA?
Acid Phosphatase Test (K873726) received a 510(k) decision of Substantially Equivalent on January 27, 1988, 134 days after the submission was received.
What is the product code of K873726?
The FDA product code is CKE – Acid Phosphatase, Thymolphthale Inmonophosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.