FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Xpert Carba-R
K Number: K160901
·
Decision Jun 29, 2016
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
50
Review Days
89
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Basic Information
- Device Name
- Xpert Carba-R
- K Number
- K160901
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cepheid
- Date Received
- April 1, 2016
- Decision Date
- June 29, 2016
- Product Code
- POC
- 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 |
|---|---|---|---|
| POC | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (POC), ordered by most recent decision date.
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FDA 510(k)
FDA Class 2
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| DEN240016 | Xpert HCV; GeneXpert Xpress System | Jun 27, 2024 | Unknown |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress System | Oct 19, 2023 | Substantially Equivalent |
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | Sep 27, 2023 | Substantially Equivalent |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Jun 7, 2022 | Substantially Equivalent |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | May 9, 2022 | Substantially Equivalent |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Feb 9, 2022 | Substantially Equivalent |