ANTI-ENA TEST
FDA 510(k) clearance K831292 · decided 1983-07-18
Clearance details
- K-number
- K831292
- Device name
- ANTI-ENA TEST
- Applicant
- Meloy Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-20
- Decision date
- 1983-07-18
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- LKO
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.