FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
K Number: K894609
·
Decision Sep 19, 1989
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
1
Review Days
61
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
- K Number
- K894609
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Mardx, Inc.
- Date Received
- July 20, 1989
- Decision Date
- September 19, 1989
- Product Code
- LSR
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LSR), ordered by most recent decision date.
Lyme-ID IgG Test; Bio-ID800
FDA 510(k)
FDA Class 2
·Microbiology
iDart Lyme IgM ImmunoBlot Kit
FDA 510(k)
FDA Class 2
·Microbiology
iDart Lyme IgG ImmunoBlot Kit
FDA 510(k)
FDA Class 2
·Microbiology
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
FDA 510(k)
FDA Class 2
·Microbiology
Viramed Borrela All-In-One ViraChip Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
FDA 510(k)
FDA Class 2
·Microbiology