Healgen Rapid Check COVID-19/Flu A&B Antigen Test— 510(k) DEN240029
UnknownHealgen
FDA 510(k) clearance DEN240029 for Healgen Rapid Check COVID-19/Flu A&B Antigen Test, Unknown on 2024-10-07. Applicant: Healgen. Device class: 2.
Clearance details
- Applicant
- Healgen
- Product code
- Product code SCA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3987
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Houston, TX, US
Recent devices under product code SCA
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Data sourced from openFDA. This site is unofficial and independent of the FDA.