FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POCKIT HSV 2 RAPID TEST
K Number: K983886
·
Decision Aug 19, 1999
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
37
Applicant Total
1
Review Days
290
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Basic Information
- Device Name
- POCKIT HSV 2 RAPID TEST
- K Number
- K983886
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnology , Ltd.
- Date Received
- November 2, 1998
- Decision Date
- August 19, 1999
- Product Code
- LGC
- 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 |
|---|---|---|---|
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | FDA class 2 | Microbiology |
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