FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
K Number: K220715
·
Decision Feb 10, 2023
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
3
Review Days
336
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Basic Information
- Device Name
- ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
- K Number
- K220715
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Artsmedia Denmark Aps
- Date Received
- March 11, 2022
- Decision Date
- February 10, 2023
- Product Code
- MQL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| MQL | Media, Reproductive | FDA class 2 | Obstetrics/Gynecology |
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