FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
HUMAN LYME IGM WESTERN BLOT KIT
K Number: K970768
·
Decision Apr 9, 1998
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
4
Review Days
402
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Basic Information
- Device Name
- HUMAN LYME IGM WESTERN BLOT KIT
- K Number
- K970768
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cambridge Diagnostics Ireland, Ltd.
- Date Received
- March 3, 1997
- Decision Date
- April 9, 1998
- 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 |
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