FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
RI MSC (MIGRATION SEDIMENTATION CHAMBER)
K Number: K112413
·
Decision Jul 13, 2012
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
49
Applicant Total
7
Review Days
326
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Basic Information
- Device Name
- RI MSC (MIGRATION SEDIMENTATION CHAMBER)
- K Number
- K112413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Research Instruments , Ltd.
- Date Received
- August 22, 2011
- Decision Date
- July 13, 2012
- Product Code
- MQK
- 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 |
|---|---|---|---|
| MQK | Labware, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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|---|---|---|---|
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| K083208 | SATURN ACTIVE LASER SYSTEM | Aug 25, 2009 | Substantially Equivalent |
| K060764 | SATURN 3 LASER SYSTEM | Mar 12, 2007 | Substantially Equivalent |
| K003142 | MICROMANIPULATOR | Nov 22, 2000 | Substantially Equivalent |
| K991261 | ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET | Aug 5, 1999 | Substantially Equivalent |