FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HERPES VIRUS AGGLUTINATION TEST
K Number: K842887
·
Decision Feb 26, 1985
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
15
Applicant Total
5
Review Days
218
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Basic Information
- Device Name
- HERPES VIRUS AGGLUTINATION TEST
- K Number
- K842887
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Scientific Research
- Date Received
- July 23, 1984
- Decision Date
- February 26, 1985
- Product Code
- GQO
- 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 |
|---|---|---|---|
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | FDA class 2 | Microbiology |
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Other Clearances by Scientific Research
| K Number | Device Name | ||
|---|---|---|---|
| K912420 | ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM | Sep 23, 1991 | Substantially Equivalent |
| K843077 | ELISA FOR HERPES SIMPLEX VIRUS | Jun 21, 1985 | Substantially Equivalent |
| K843369 | AGGLUTINATION TEST FOR TOTAL IGE | Nov 14, 1984 | Substantially Equivalent |
| K843710 | ELISA FOR TOTAL IGE | Oct 22, 1984 | Substantially Equivalent |