FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K Number: K062213
·
Decision Dec 8, 2006
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
55
Applicant Total
82
Review Days
129
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Basic Information
- Device Name
- BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K Number
- K062213
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad Laboratories, Inc.
- Date Received
- August 1, 2006
- Decision Date
- December 8, 2006
- Product Code
- LSE
- 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 |
|---|---|---|---|
| LSE | Epstein-Barr Virus, Other | FDA class 1 | Microbiology |
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