DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
FDA 510(k) clearance K082763 · decided 2008-11-12
Clearance details
- K-number
- K082763
- Device name
- DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
- Applicant
- Diazyme Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2008-09-22
- Decision date
- 2008-11-12
- Days to decision
- 51 days
- Clearance type
- Special
- Product code
- MZU
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Poway, 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 |
|---|---|---|
| DIAZYME SODIUM ENZYMATIC ASSAY (K042189) | Diazyme Laboratories | 2004-10-07 |
Recalls involving this device
No recalls on record reference this clearance.