DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM— 510(k) K960182
Substantially EquivalentMardx Diagnostics, Inc.
FDA 510(k) clearance K960182 for DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM, Substantially Equivalent on 1996-03-20. Applicant: Mardx Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Mardx Diagnostics, Inc.
- Product code
- Code LRM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code LRM
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- K950829 — MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
- K894224 — MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
- K894293 — MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.