| Device Type ID | 3343 |
| Device Name | Supplement, Culture Media |
| Regulation Description | Supplement For Culture Media. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.2450 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JSK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3343 |
| Device | Supplement, Culture Media |
| Product Code | JSK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Supplement For Culture Media. |
| CFR Regulation Number | 866.2450 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Acumedia Manufacturers, Inc. | III | Jun-01-2017 |
| 2 | Remel Inc | II | Mar-02-2015 |
| 3 | Remel Inc | II | Dec-12-2014 |
| 4 | Remel Inc | II | Nov-10-2014 |
| 5 | Remel Inc | II | Feb-26-2014 |