FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BTA STAT TEST PRESCRIPTION HOME USE
K Number: K974845
·
Decision Dec 8, 1998
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
8
Applicant Total
3
Review Days
355
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Basic Information
- Device Name
- BTA STAT TEST PRESCRIPTION HOME USE
- K Number
- K974845
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bard Diagnostic Sciences,Inc.
- Date Received
- December 18, 1997
- Decision Date
- December 8, 1998
- Product Code
- MMW
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| MMW | System, Test, Tumor Marker, Monitoring, Bladder | FDA class 2 | Immunology |
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