DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
FDA 510(k) clearance K042191 · decided 2004-10-29
Clearance details
- K-number
- K042191
- Device name
- DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
- Applicant
- Diazyme Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2004-08-12
- Decision date
- 2004-10-29
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- MZV
- Device class
- 2
- Regulation number
- 862.1600
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Piccolo Potassium Test System (K200865) | Abaxis, Inc. | 2021-10-20 |
| DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL (K091455) | Diazyme Laboratories | 2009-08-14 |
| MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A (K053566) | Diazyme Laboratories | 2006-02-15 |
Recalls involving this device
No recalls on record reference this clearance.