| Device Type ID | 314 |
| Device Name | Lipase-esterase, Enzymatic, Photometric, Lipase |
| Regulation Description | Lipase Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1465 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CHI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 314 |
| Device | Lipase-esterase, Enzymatic, Photometric, Lipase |
| Product Code | CHI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Lipase Test System. |
| CFR Regulation Number | 862.1465 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 8 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Low Test Results | 3 |
Mechanical Problem | 3 |
Insufficient Information | 2 |
Probe | 1 |
Device Ingredient Or Reagent Problem | 1 |
| Total Device Problems | 24 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Laboratories, Inc | II | Oct-28-2014 |
| 2 | Medica Corporation | II | Mar-21-2018 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | Nov-14-2018 |
| 4 | Siemens Healthcare Diagnostics, Inc. | II | May-10-2018 |
| 5 | Siemens Healthcare Diagnostics, Inc. | II | Apr-20-2015 |