Rapid-i™ Kit
Labware, Assisted Reproduction
Vitrolife Sweden AB
The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Rapid-i™ Kit.
Pre-market Notification Details
| Device ID | K181461 |
| 510k Number | K181461 |
| Device Name: | Rapid-i™ Kit |
| Classification | Labware, Assisted Reproduction |
| Applicant | Vitrolife Sweden AB Gustaf Werners Gata 2 Vastra Frolunda, SE 421 32 |
| Contact | Nina Arvidsson |
| Correspondent | Nina Arvidsson Vitrolife Sweden AB Gustaf Werners Gata 2 Se-421 32 Vastra Frolunda, SE |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-04 |
| Decision Date | 2019-01-04 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025914395 | K181461 | 000 |
| 17350025912247 | K181461 | 000 |
| 17350025912230 | K181461 | 000 |
| 17350025912223 | K181461 | 000 |
| 17350025912216 | K181461 | 000 |
Trademark Results [Rapid-i]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RAPID-I 79355256 not registered Live/Pending |
Vitrolife Sweden AB 2022-10-07 |
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