FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYCHACO FIA-ABS TEST FOR SYPHILIS
K Number: K831296
·
Decision Jul 26, 1983
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
3
Review Days
97
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Basic Information
- Device Name
- POLYCHACO FIA-ABS TEST FOR SYPHILIS
- K Number
- K831296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Parasitic Disease Consultants
- Date Received
- April 20, 1983
- Decision Date
- July 26, 1983
- Product Code
- JWL
- 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 |
|---|---|---|---|
| JWL | Antigen, Treponema Pallidum For Fta-Abs Test | FDA class 2 | Microbiology |
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