FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
K Number: K100148
·
Decision May 24, 2010
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
9
Applicant Total
14
Review Days
125
Basic Information
- Device Name
- SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
- K Number
- K100148
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3332
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FOCUS DIAGNOSTICS, INC.
- Date Received
- January 19, 2010
- Decision Date
- May 24, 2010
- Product Code
- OQW
- 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 |
|---|---|---|---|
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | FDA class 2 | Microbiology |
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