| Device Type ID | 3444 |
| Device Name | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| 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 | 866.1640 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LRG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 3444 |
| Device | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Product Code | LRG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| CFR Regulation Number | 866.1640 [🔎] |
| Device Problems | |
|---|---|
Product Quality Problem | 14 |
Adverse Event Without Identified Device Or Use Problem | 10 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Output Problem | 1 |
Break | 1 |
Leak / Splash | 1 |
Electrical Shorting | 1 |
Pressure Problem | 1 |
Device Emits Odor | 1 |
Smoking | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Cable | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 36 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc. | II | Jul-02-2014 |