ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT— 510(k) K951850
Substantially EquivalentHelix Diagnostics, Inc.
FDA 510(k) clearance K951850 for ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT, Substantially Equivalent on 1995-07-18. Applicant: Helix Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Helix Diagnostics, Inc.
- Product code
- Code LJM
- 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 LJM
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