FDA 510(k)
FDA class 1
Substantially Equivalent
🇰🇷 South Korea
Ensol EnTM Specimen Collection and Transport System
K Number: K220908
·
Decision Aug 29, 2024
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
1
Review Days
884
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Basic Information
- Device Name
- Ensol EnTM Specimen Collection and Transport System
- K Number
- K220908
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ensol Biosciences, Inc.
- Date Received
- March 29, 2022
- Decision Date
- August 29, 2024
- Product Code
- JSM
- 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 |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | FDA class 1 | Microbiology |
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