FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
VELOGENE RAPID MRSA IDENTIFICATION ASSAY
K Number: K990640
·
Decision Jul 9, 1999
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
9
Applicant Total
3
Review Days
133
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Basic Information
- Device Name
- VELOGENE RAPID MRSA IDENTIFICATION ASSAY
- K Number
- K990640
- 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
- February 26, 1999
- Decision Date
- July 9, 1999
- 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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