FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Healgen Strep A Rapid Test Strip (Throat Swab)
K Number: K212623
·
Decision Mar 16, 2022
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
43
Applicant Total
27
Review Days
210
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Basic Information
- Device Name
- Healgen Strep A Rapid Test Strip (Throat Swab)
- K Number
- K212623
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healgen Scientific,, LLC
- Date Received
- August 18, 2021
- Decision Date
- March 16, 2022
- Product Code
- GTY
- 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 |
|---|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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|---|---|---|---|
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| K232377 | Healgen Rapid COVID-19 Antigen Test | Apr 19, 2024 | Substantially Equivalent |
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