FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SeraQuest HSV Type 2 Specific IgG
K Number: K181514
·
Decision Jun 13, 2019
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
9
Applicant Total
3
Review Days
370
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Basic Information
- Device Name
- SeraQuest HSV Type 2 Specific IgG
- K Number
- K181514
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quest International, Inc.
- Date Received
- June 8, 2018
- Decision Date
- June 13, 2019
- Product Code
- MYF
- 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 |
|---|---|---|---|
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | FDA class 2 | Microbiology |
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