FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
K Number: K151906
·
Decision Oct 6, 2015
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
8
Applicant Total
15
Review Days
85
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Basic Information
- Device Name
- ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
- K Number
- K151906
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3309
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Luminex Corporation
- Date Received
- July 13, 2015
- Decision Date
- October 6, 2015
- Product Code
- PGI
- 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 |
|---|---|---|---|
| PGI | Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | FDA class 2 | Microbiology |
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|---|---|---|---|
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| K191742 | ARIES MRSA Assay | Sep 25, 2019 | Substantially Equivalent |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | Oct 30, 2017 | Substantially Equivalent |
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| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | May 2, 2017 | Substantially Equivalent |
| K162772 | ARIES GBS Assay | Dec 23, 2016 | Substantially Equivalent |