Modification to: Diazyme Potassium Enzymatic Assay, Model DZ113A
FDA 510(k) K053566 · Diazyme Laboratories
510(k) numberK053566
Submission
- Device name
- Modification to: Diazyme Potassium Enzymatic Assay, Model DZ113A
- Applicant
- Diazyme Laboratories
San Diego, CA, US - Received
- December 22, 2005
- Decision date
- February 15, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MZV – Test, System, Potassium, Enzymatic Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MZV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200865 | Piccolo Potassium Test SystemMZV · Dual Track | Abaxis, Inc. | 10/20/2021SE |
| K091455 | Diazyme Liquid Stable Enzymatic Potassium Assay Kit, Model DZ113C-X, Diazyme Liquid…MZV · Traditional | Diazyme Laboratories | 08/14/2009SE |
| K042191 | Diazyme Potassium Enzymatic Assay KitMZV · Traditional | Diazyme Laboratories | 10/29/2004SE |
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Questions and answers
When was Modification to: Diazyme Potassium Enzymatic Assay, Model DZ113A cleared by the FDA?
Modification to: Diazyme Potassium Enzymatic Assay, Model DZ113A (K053566) received a 510(k) decision of Substantially Equivalent on February 15, 2006, 55 days after the submission was received.
What is the product code of K053566?
The FDA product code is MZV – Test, System, Potassium, Enzymatic Method, a Class II (moderate risk) device regulated under 21 CFR 862.1600.