The following data is part of a premarket notification filed by Research Instruments Ltd. with the FDA for Ri Msc (migration Sedimentation Chamber).
| Device ID | K112413 |
| 510k Number | K112413 |
| Device Name: | RI MSC (MIGRATION SEDIMENTATION CHAMBER) |
| Classification | Labware, Assisted Reproduction |
| Applicant | RESEARCH INSTRUMENTS LTD. BICKLAND INDUSTRIAL PARK Falmouth, Cornwall, GB Tr11 4ta |
| Contact | David Lansdowne |
| Correspondent | David Lansdowne RESEARCH INSTRUMENTS LTD. BICKLAND INDUSTRIAL PARK Falmouth, Cornwall, GB Tr11 4ta |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2012-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060170180181 | K112413 | 000 |