MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
FDA 510(k) clearance K053566 · decided 2006-02-15
Clearance details
- K-number
- K053566
- Device name
- MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
- Applicant
- Diazyme Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2005-12-22
- Decision date
- 2006-02-15
- Days to decision
- 55 days
- Clearance type
- Special
- 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 |
| DIAZYME POTASSIUM ENZYMATIC ASSAY KIT (K042191) | Diazyme Laboratories | 2004-10-29 |
Recalls involving this device
No recalls on record reference this clearance.