The following data is part of a premarket notification filed by Kitazato Corporation with the FDA for Sequential Culture Media (fertilization Medium [without Hsa/rha, With Hsa, With Rha], Cleavage Medium [without Hsa/rha, With Hsa, With Rha], Blastocyst Medium [without Hsa/rha, With Hsa, With Rha]).
| Device ID | K200249 |
| 510k Number | K200249 |
| Device Name: | Sequential Culture Media (Fertilization Medium [without HSA/rHA, With HSA, With RHA], Cleavage Medium [without HSA/rHA, With HSA, With RHA], Blastocyst Medium [without HSA/rHA, With HSA, With RHA]) |
| Classification | Media, Reproductive |
| Applicant | Kitazato Corporation 81 Nakajima Fuji-shi, JP 416-0907 |
| Contact | Futoshi Inoue |
| Correspondent | Audrey Swearingen Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-03 |
| Decision Date | 2020-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04573316381461 | K200249 | 000 |
| 04573316381454 | K200249 | 000 |
| 04573316381447 | K200249 | 000 |
| 04573316381430 | K200249 | 000 |
| 04573316381423 | K200249 | 000 |
| 04573316381416 | K200249 | 000 |
| 04573316381409 | K200249 | 000 |
| 04573316381393 | K200249 | 000 |