FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
K Number: K010858
·
Decision May 24, 2001
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
9
Applicant Total
3
Review Days
63
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Basic Information
- Device Name
- VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
- K Number
- K010858
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Id Biomedical Corp.
- Date Received
- March 22, 2001
- Decision Date
- May 24, 2001
- Product Code
- MYI
- 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 |
|---|---|---|---|
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | FDA class 2 | Microbiology |
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