FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
K Number: K150962
·
Decision Aug 28, 2015
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
11
Applicant Total
4
Review Days
140
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Basic Information
- Device Name
- Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
- K Number
- K150962
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Focus Diagnostics
- Date Received
- April 10, 2015
- Decision Date
- August 28, 2015
- Product Code
- OQO
- 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 |
|---|---|---|---|
| OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | FDA class 2 | Microbiology |
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