MARDX LYME DISEASE EIA (IGM) TEST SYSTEM— 510(k) K894293
Substantially EquivalentMardx Diagnostics, Inc.
FDA 510(k) clearance K894293 for MARDX LYME DISEASE EIA (IGM) TEST SYSTEM, Substantially Equivalent on 1989-08-21. Applicant: Mardx Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Mardx Diagnostics, Inc.
- Product code
- Code LSR
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scotch Plains, NJ, US
Recent devices under product code LSR
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view all- K964787 — MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
- K951709 — MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
- K950829 — MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
- K960182 — DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
- K894224 — MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.