FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K Number: K091724
·
Decision Nov 13, 2009
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
18
Applicant Total
190
Review Days
155
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Basic Information
- Device Name
- BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
- K Number
- K091724
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson & CO
- Date Received
- June 11, 2009
- Decision Date
- November 13, 2009
- Product Code
- MKZ
- 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 |
|---|---|---|---|
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | FDA class 1 | Microbiology |
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