The following data is part of a premarket notification filed by Origio A/s with the FDA for Origio(r) Sequential Blast Tm; Origio(r) Sequential Blast Tm With Phenol Red.
| Device ID | K133387 |
| 510k Number | K133387 |
| Device Name: | ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED |
| Classification | Media, Reproductive |
| Applicant | ORIGIO A/S Knardrupvej 2 Malov, DK 2760 |
| Contact | Tove Kjaer |
| Correspondent | Tove Kjaer ORIGIO A/S Knardrupvej 2 Malov, DK 2760 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-05 |
| Decision Date | 2014-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937832082 | K133387 | 000 |
| 00888937832051 | K133387 | 000 |
| 00888937804331 | K133387 | 000 |
| 00888937804317 | K133387 | 000 |