FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SSS-NX (Serum Substitute Supplement-NX)
K Number: K233764
·
Decision Apr 24, 2024
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
253
Applicant Total
2
Review Days
152
Basic Information
- Device Name
- SSS-NX (Serum Substitute Supplement-NX)
- K Number
- K233764
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIFILM Irvine Scientific
- Date Received
- November 24, 2023
- Decision Date
- April 24, 2024
- 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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Other Clearances by FUJIFILM Irvine Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K241341 | cryo-GO Vitrification Device | Sep 26, 2024 | Substantially Equivalent |