| Device Type ID | 2014 |
| Device Name | Media, Culture, Ex Vivo, Tissue And Cell |
| Regulation Description | Tissue Culture Media For Human Ex Vivo Tissue And Cell Culture Processing Applications. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5885 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NDS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2014 |
| Device | Media, Culture, Ex Vivo, Tissue And Cell |
| Product Code | NDS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tissue Culture Media For Human Ex Vivo Tissue And Cell Culture Processing Applications. |
| CFR Regulation Number | 876.5885 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Life Technologies, Corp. | II | Jul-25-2018 |