DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
FDA 510(k) clearance K980759 · decided 1998-04-23
Clearance details
- K-number
- K980759
- Device name
- DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
- Applicant
- Diamedix Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-27
- Decision date
- 1998-04-23
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- LLL
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Te recall (Z-1620-2012) | Diamedix Corporation | 2012-05-21 |