| Device Type ID | 2314 |
| Device Name | Instrument, Coagulation, Automated |
| Regulation Description | Coagulation Instrument. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.5400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GKP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2314 |
| Device | Instrument, Coagulation, Automated |
| Product Code | GKP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Coagulation Instrument. |
| CFR Regulation Number | 864.5400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INSTRUMENTATION LABORATORY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INSTRUMENTATION LABORATORY CO. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 34 |
Low Test Results | 6 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 6 |
Incorrect Or Inadequate Test Results | 5 |
High Test Results | 5 |
Use Of Device Problem | 4 |
Data Problem | 3 |
Device Operates Differently Than Expected | 3 |
Temperature Problem | 3 |
Mechanical Problem | 3 |
Patient Data Problem | 3 |
Device Handling Problem | 2 |
Fluid Leak | 2 |
Fail-Safe Problem | 2 |
Fire | 1 |
Flushing Problem | 1 |
Computer Software Problem | 1 |
| Total Device Problems | 84 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Instrumentation Laboratory Co. | II | Jul-16-2014 |