SALICYLATE ASSAY
FDA 510(k) clearance K961131 · decided 1996-04-29
Clearance details
- K-number
- K961131
- Device name
- SALICYLATE ASSAY
- Applicant
- Diagnostic Reagents, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-21
- Decision date
- 1996-04-29
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- DKJ
- Device class
- 2
- Regulation number
- 862.3830
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum recall (Z-2884-2016) | Microgenics Corporation | 2016-09-23 |