Dimension (TM) Clinical Chemistry System
FDA 510(k) K864230 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK864230
Submission
- Device name
- Dimension (TM) Clinical Chemistry System
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- October 28, 1986
- Decision date
- November 28, 1986
- 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 |
| 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 |
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| K953724 | Cronex Radiation Therapy CassetteIXA · Traditional | 09/06/1995SE |
| K951441 | Dupont Aca Digoxin (DGN a) MethodKXT · Traditional | 06/01/1995SE |
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Questions and answers
When was Dimension (TM) Clinical Chemistry System cleared by the FDA?
Dimension (TM) Clinical Chemistry System (K864230) received a 510(k) decision of Substantially Equivalent on November 28, 1986, 31 days after the submission was received.
What is the product code of K864230?
The FDA product code is CKE – Acid Phosphatase, Thymolphthale Inmonophosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.