ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
FDA 510(k) clearance K931495 · decided 1993-07-16
Clearance details
- K-number
- K931495
- Device name
- ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
- Applicant
- Helix Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-25
- Decision date
- 1993-07-16
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- LLL
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- West Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.