The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Rapid-i Kit.
| Device ID | K140207 |
| 510k Number | K140207 |
| Device Name: | RAPID-I KIT |
| Classification | Labware, Assisted Reproduction |
| Applicant | VITROLIFE SWEDEN AB 1111 PENNSYLVANIA AVENUE,NW Washington, DC 20004 |
| Contact | Anthony T Pavel |
| Correspondent | Anthony T Pavel VITROLIFE SWEDEN AB 1111 PENNSYLVANIA AVENUE,NW Washington, DC 20004 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-28 |
| Decision Date | 2014-12-18 |
| Summary: | summary |