The following data is part of a premarket notification filed by Origio A/s with the FDA for Origio Sequential Fert, Origio Sequential Fert With Phenol Red, Origio Sequential Cleav, Origio Sequential Cleav, Origio.
| Device ID | K133912 |
| 510k Number | K133912 |
| Device Name: | ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO |
| Classification | Media, Reproductive |
| Applicant | ORIGIO A/S Knardrupvej 2 Maaloev, DK Dk-2760 |
| Contact | Tove Kjaer |
| Correspondent | Tove Kjaer ORIGIO A/S Knardrupvej 2 Maaloev, DK Dk-2760 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-12-23 |
| Decision Date | 2014-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937804294 | K133912 | 000 |
| 00888937028393 | K133912 | 000 |
| 00888937028409 | K133912 | 000 |
| 00888937028416 | K133912 | 000 |
| 00888937028430 | K133912 | 000 |
| 00888937028447 | K133912 | 000 |
| 00888937028454 | K133912 | 000 |
| 00888937028461 | K133912 | 000 |
| 00888937804157 | K133912 | 000 |
| 00888937804171 | K133912 | 000 |
| 00888937804195 | K133912 | 000 |
| 00888937804218 | K133912 | 000 |
| 00888937804232 | K133912 | 000 |
| 00888937804256 | K133912 | 000 |
| 00888937804270 | K133912 | 000 |
| 00888937028386 | K133912 | 000 |