FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRU RSV
K Number: K071101
·
Decision Oct 18, 2007
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
38
Review Days
182
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Basic Information
- Device Name
- TRU RSV
- K Number
- K071101
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3405
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meridian Bioscience, Inc.
- Date Received
- April 19, 2007
- Decision Date
- October 18, 2007
- Product Code
- GOG
- 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 |
|---|---|---|---|
| GOG | Antisera, Cf, Poliovirus 1-3 | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GOG), ordered by most recent decision date.
RSV OIA
FDA 510(k)
FDA Class 1
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POLIO TYPE I CF ANTIGEN, & TYPE II, III
FDA 510(k)
FDA Class 1
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