FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Healgen Rapid Check COVID-19/Flu A&B Antigen Test
K Number: DEN240029
·
Decision Oct 7, 2024
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
10
Applicant Total
1
Review Days
122
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Basic Information
- Device Name
- Healgen Rapid Check COVID-19/Flu A&B Antigen Test
- K Number
- DEN240029
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.3987
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- Healgen
- Date Received
- June 7, 2024
- Decision Date
- October 7, 2024
- Product Code
- SCA
- 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 |
|---|---|---|---|
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | FDA class 2 | Microbiology |
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