FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST
K Number: K852751
·
Decision Aug 20, 1985
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
31
Applicant Total
4
Review Days
53
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Basic Information
- Device Name
- TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST
- K Number
- K852751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Preco, Inc.
- Date Received
- June 28, 1985
- Decision Date
- August 20, 1985
- Product Code
- GMQ
- 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 |
|---|---|---|---|
| GMQ | Antigens, Nontreponemal, All | FDA class 2 | Microbiology |
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