AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
FDA 510(k) clearance K033921 · decided 2004-03-10
Clearance details
- K-number
- K033921
- Device name
- AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
- Applicant
- Diagnostic Chemicals , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-18
- Decision date
- 2004-03-10
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- JIF
- Device class
- 1
- Regulation number
- 862.1065
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Charlottetown, P.E., CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VIT recall (Z-1078-2017) | Sekisui Diagnostics P.E.I. Inc. | 2017-01-23 |