ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT— 510(k) K940510
Substantially EquivalentHelix Diagnostics, Inc.
FDA 510(k) clearance K940510 for ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT, Substantially Equivalent on 1994-04-20. Applicant: Helix Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Helix Diagnostics, Inc.
- Product code
- Code LKP
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Sacramento, CA, US
Recent devices under product code LKP
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