FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT HSV EIA
K Number: K843622
·
Decision May 20, 1985
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
37
Applicant Total
883
Review Days
248
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Basic Information
- Device Name
- ABBOTT HSV EIA
- K Number
- K843622
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- September 14, 1984
- Decision Date
- May 20, 1985
- Product Code
- LGC
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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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