FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
K Number: K000626
·
Decision May 23, 2000
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
253
Applicant Total
7
Review Days
96
Basic Information
- Device Name
- SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
- K Number
- K000626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
- Date Received
- February 17, 2000
- Decision Date
- May 23, 2000
- 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 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
| K Number | Device Name | ||
|---|---|---|---|
| K000619 | SCANDINAVIAN IVF SCIENCES AB, G2.2 | Jun 27, 2000 | Substantially Equivalent |
| K000627 | SCANDINAVIAN IVF SCIENCES AB, HYBASE-1 | Jun 13, 2000 | Substantially Equivalent |
| K000625 | SCANDINAVIAN IVF SCIENCES AB, G1.2 | May 23, 2000 | Substantially Equivalent |
| K000618 | SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1 | May 17, 2000 | Substantially Equivalent |
| K000623 | SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 | May 16, 2000 | Substantially Equivalent |
| K000621 | SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100 | May 16, 2000 | Substantially Equivalent |