FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
K Number: K000687
·
Decision Jun 12, 2000
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
31
Applicant Total
1
Review Days
104
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Basic Information
- Device Name
- THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
- K Number
- K000687
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Beacon Biologicals, Inc.
- Date Received
- February 29, 2000
- Decision Date
- June 12, 2000
- 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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