FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
K Number: K191184
·
Decision Mar 5, 2020
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
9
Applicant Total
1
Review Days
307
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Basic Information
- Device Name
- ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
- K Number
- K191184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ssi Diagnostica A/S
- Date Received
- May 3, 2019
- Decision Date
- March 5, 2020
- Product Code
- MJH
- 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 |
|---|---|---|---|
| MJH | Legionella, Spp., Elisa | FDA class 2 | Microbiology |
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