ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST— 510(k) K000489
Substantially EquivalentHelix Diagnostics, Inc.
FDA 510(k) clearance K000489 for ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST, Substantially Equivalent on 2000-04-05. Applicant: Helix Diagnostics, Inc..
Clearance details
- Applicant
- Helix Diagnostics, Inc.
- Product code
- Code LLL
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Sacramento, CA, US
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