FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit
K Number: K160006
·
Decision May 4, 2016
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
16
Review Days
121
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Basic Information
- Device Name
- Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit
- K Number
- K160006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Irvine Scientific
- Date Received
- January 4, 2016
- Decision Date
- May 4, 2016
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQL), ordered by most recent decision date.
Ultra-Fast Warm
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CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
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Fast Warm - NX
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Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
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FDA Class 2
·Obstetrics/Gynecology
Ultra-Fast Vitri; Ultra-Fast Warm
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FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Irvine Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K914541 | SPERM MAINTENANCE MEDIUM WITH GLYCEROL | Feb 3, 1994 | Substantially Equivalent |
| K900316 | MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES | Apr 16, 1990 | Substantially Equivalent |
| K894405 | HTF WITH ALBUMIN (CATALOG NO. 9994) | Sep 22, 1989 | Substantially Equivalent |
| K894432 | MODIFIED HAM'S F-10 W/ALBUMIN | Sep 22, 1989 | Substantially Equivalent |
| K874668 | SPERM WASHING MEDIUM #9983 & MODIFIED #9984 | Mar 31, 1988 | Substantially Equivalent |
| K872203 | CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) | Aug 14, 1987 | Substantially Equivalent |
| K872088 | FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) | Aug 14, 1987 | Substantially Equivalent |
| K872102 | SPERM WASHING MEDIUM #9932 | Jul 16, 1987 | Substantially Equivalent |
| K871577 | HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES | Jul 15, 1987 | Substantially Equivalent |
| K861188 | SPERM CAPACITATION MEDIUM | Jan 6, 1987 | Substantially Equivalent |