FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
PBS(-), Phosphate Buffered Saline
K Number: K160863
·
Decision Jul 28, 2016
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
5
Review Days
121
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PBS(-), Phosphate Buffered Saline
- K Number
- K160863
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kitazato Biopharma Co., Ltd.
- Date Received
- March 29, 2016
- Decision Date
- July 28, 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
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Fast Warm - NX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ultra-Fast Vitri; Ultra-Fast Warm
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology