| Device Type ID | 3358 |
| Device Name | Device, Microtiter Diluting/dispensing |
| Regulation Description | Microtiter Diluting And Dispensing Device. |
| 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 | 866.2500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JTC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3358 |
| Device | Device, Microtiter Diluting/dispensing |
| Product Code | JTC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Microtiter Diluting And Dispensing Device. |
| CFR Regulation Number | 866.2500 [🔎] |
| Device Problems | |
|---|---|
Device Maintenance Issue | 1 |
Device Markings / Labelling Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
| Total Device Problems | 4 |