FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
K Number: K012351
·
Decision Sep 18, 2001
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
44
Applicant Total
190
Review Days
55
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Basic Information
- Device Name
- BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
- K Number
- K012351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson & CO
- Date Received
- July 25, 2001
- Decision Date
- September 18, 2001
- Product Code
- LSL
- 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 |
|---|---|---|---|
| LSL | Dna-Reagents, Neisseria | FDA class 2 | Microbiology |
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