DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
FDA 510(k) clearance K002262 · decided 2000-11-28
Clearance details
- K-number
- K002262
- Device name
- DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
- Applicant
- Diamedix Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-25
- Decision date
- 2000-11-28
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- LGC
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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***HSV 1&2 IgM***Enzyme Immunoassay Tes recall (Z-1520-2012) | Diamedix Corporation | 2012-05-10 |