Diazyme Potassium Enzymatic Assay Kit
FDA 510(k) K042191 · Diazyme Laboratories
510(k) numberK042191
Submission
- Device name
- Diazyme Potassium Enzymatic Assay Kit
- Applicant
- Diazyme Laboratories
San Diego, CA, US - Received
- August 12, 2004
- Decision date
- October 29, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K053566 | Modification to: Diazyme Potassium Enzymatic Assay, Model DZ113AMZV · Special | Diazyme Laboratories | 02/15/2006SE |
More from Diazyme Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K253069 | Lipoprotein (a) Molarity AssayDFC · Traditional | 06/16/2026SE |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M… · Traditional | 04/24/2026SE |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light…DFH · Traditional | 12/19/2025SE |
| K243462 | Diazyme Colorimetric Lithium AssayNDW · Traditional | 08/01/2025SE |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | 09/08/2022SE |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | 08/04/2022SE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional | 12/13/2021SE |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 ActivityNOE · Special | 08/06/2021SE |
| K180209 | Diazyme 1,5-AG AssayNOZ · Traditional | 10/04/2018SE |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDFH · Special | 06/26/2018SE |
Questions and answers
When was Diazyme Potassium Enzymatic Assay Kit cleared by the FDA?
Diazyme Potassium Enzymatic Assay Kit (K042191) received a 510(k) decision of Substantially Equivalent on October 29, 2004, 78 days after the submission was received.
What is the product code of K042191?
The FDA product code is MZV – Test, System, Potassium, Enzymatic Method, a Class II (moderate risk) device regulated under 21 CFR 862.1600.