DIAZYME LITHIUM ENZYMATIC ASSAY KIT
FDA 510(k) clearance K033360 · decided 2003-12-23
Clearance details
- K-number
- K033360
- Device name
- DIAZYME LITHIUM ENZYMATIC ASSAY KIT
- Applicant
- General Atomics
- Decision
- Substantially Equivalent
- Date received
- 2003-10-21
- Decision date
- 2003-12-23
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- JII
- Device class
- 2
- Regulation number
- 862.3560
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B (K082001) | Diazyme Laboratories | 2008-12-05 |
| UROTEST GPH (K912244) | In Wha Pharmaceutical Co., Ltd. | 1991-11-22 |
Recalls involving this device
No recalls on record reference this clearance.