FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RSV OIA
K Number: K021172
·
Decision Sep 13, 2002
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
5
Review Days
154
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Basic Information
- Device Name
- RSV OIA
- K Number
- K021172
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3405
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thermo Biostar, Inc.
- Date Received
- April 12, 2002
- Decision Date
- September 13, 2002
- 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 |
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