DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
FDA 510(k) clearance K091455 · decided 2009-08-14
Clearance details
- K-number
- K091455
- Device name
- DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
- Applicant
- Diazyme Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2009-05-18
- Decision date
- 2009-08-14
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MZV
- Device class
- 2
- Regulation number
- 862.1600
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Poway, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Diazyme Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A (K053566) | Diazyme Laboratories | 2006-02-15 |
| DIAZYME POTASSIUM ENZYMATIC ASSAY KIT (K042191) | Diazyme Laboratories | 2004-10-29 |
Recalls involving this device
No recalls on record reference this clearance.