The following data is part of a premarket notification filed by Medicult A/s with the FDA for Blastassist Without Phenol Red, Model Ref 1215, Blastassist With Phenol Red, Model Ref 1216.
| Device ID | K080172 |
| 510k Number | K080172 |
| Device Name: | BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 |
| Classification | Media, Reproductive |
| Applicant | MEDICULT A/S 9915 CAM.CHIRIMOLLA San Diego, CA 92131 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi MEDICULT A/S 9915 CAM.CHIRIMOLLA San Diego, CA 92131 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-01-24 |
| Decision Date | 2008-12-18 |
| Summary: | summary |