| Device Type ID | 3345 |
| Device Name | Culture Media, Non-propagating Transport |
| Regulation Description | Transport Culture Medium. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.2390 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JSM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 3345 |
| Device | Culture Media, Non-propagating Transport |
| Product Code | JSM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Transport Culture Medium. |
| CFR Regulation Number | 866.2390 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COPAN ITALIA S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GREINER BIO-ONE NA INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICAL CHEMICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PURITAN MEDICAL PRODUCTS LLC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Material Protrusion / Extrusion | 30 |
Leak / Splash | 27 |
Incorrect Or Inadequate Test Results | 19 |
Delivered As Unsterile Product | 11 |
Short Fill | 10 |
Volume Accuracy Problem | 9 |
Device Contamination With Chemical Or Other Material | 6 |
Device Markings / Labelling Problem | 4 |
Component Missing | 3 |
Use Of Device Problem | 2 |
Contamination / Decontamination Problem | 2 |
Product Quality Problem | 2 |
Detachment Of Device Component | 2 |
Material Deformation | 1 |
Complete Blockage | 1 |
Difficult To Insert | 1 |
Detachment Of Device Or Device Component | 1 |
Packaging Problem | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Material Discolored | 1 |
Material Twisted / Bent | 1 |
| Total Device Problems | 135 |