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 |