ANTI-JO-1 MICROASSAY
FDA 510(k) clearance K911679 · decided 1991-09-23
Clearance details
- K-number
- K911679
- Device name
- ANTI-JO-1 MICROASSAY
- Applicant
- Diamedix Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-15
- Decision date
- 1991-09-23
- Days to decision
- 161 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
No recalls on record reference this clearance.