Ri MSC (Migration Sedimentation Chamber)
FDA 510(k) K112413 · Research Instruments , Ltd.
510(k) numberK112413
Submission
- Device name
- Ri MSC (Migration Sedimentation Chamber)
- Applicant
- Research Instruments , Ltd.
Falmouth, Cornwall, GB - Received
- August 22, 2011
- Decision date
- July 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQK – Labware, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6160
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Ri MSC (Migration Sedimentation Chamber) cleared by the FDA?
Ri MSC (Migration Sedimentation Chamber) (K112413) received a 510(k) decision of Substantially Equivalent on July 13, 2012, 326 days after the submission was received.
What is the product code of K112413?
The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.