FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
K Number: K133140
·
Decision Nov 15, 2013
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
31
Applicant Total
190
Review Days
29
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Basic Information
- Device Name
- BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
- K Number
- K133140
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 866.3480
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson & CO
- Date Received
- October 17, 2013
- Decision Date
- November 15, 2013
- Product Code
- GQG
- 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 |
|---|---|---|---|
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | FDA class 1 | Microbiology |
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|---|---|---|---|
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| K141474 | BECTON DICKINSON INTELLIPORT SYSTEM | Dec 18, 2014 | Substantially Equivalent |
| K140446 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | May 20, 2014 | Substantially Equivalent |
| K140448 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | May 20, 2014 | Substantially Equivalent |
| K140591 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR | May 14, 2014 | Substantially Equivalent |
| K133138 | BD Veritor System Flu A+B Assay | Nov 13, 2013 | Substantially Equivalent |
| K130268 | BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY | Aug 23, 2013 | Substantially Equivalent |
| K131301 | BD FACS SAMPLE PREP ASSISTANT III | Aug 2, 2013 | Substantially Equivalent |
| K131358 | BD PEN NEEDLE | Jul 16, 2013 | Substantially Equivalent |