FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
K Number: K193081
·
Decision Dec 17, 2021
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
22
Applicant Total
1
Review Days
773
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Basic Information
- Device Name
- Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
- K Number
- K193081
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3393
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rheonix, Inc.
- Date Received
- November 5, 2019
- Decision Date
- December 17, 2021
- Product Code
- QEP
- 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 |
|---|---|---|---|
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | FDA class 2 | Microbiology |
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