| Device Type ID | 587 |
| Device Name | Acid, Lactic, Enzymatic Method |
| Regulation Description | Lactic Acid 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 | 862.1450 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KHP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 587 |
| Device | Acid, Lactic, Enzymatic Method |
| Product Code | KHP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Lactic Acid Test System. |
| CFR Regulation Number | 862.1450 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 9 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 6 |
Device Displays Incorrect Message | 3 |
Display Difficult To Read | 2 |
False Negative Result | 2 |
Computer Operating System Problem | 1 |
Probe | 1 |
Communication Or Transmission Problem | 1 |
High Readings | 1 |
| Total Device Problems | 26 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Laboratories | II | Nov-09-2016 |
| 2 | Beckman Coulter Inc. | II | Jun-08-2016 |
| 3 | Beckman Coulter Inc. | II | Jan-28-2015 |
| 4 | Horiba Instruments Inc | II | Feb-02-2016 |
| 5 | Ortho-Clinical Diagnostics | II | Oct-17-2016 |
| 6 | Siemens Healthcare Diagnostics Inc | III | Aug-19-2016 |
| 7 | Siemens Healthcare Diagnostics Inc | II | Sep-24-2015 |
| 8 | Siemens Healthcare Diagnostics Inc | II | Aug-28-2015 |
| 9 | Siemens Healthcare Diagnostics Inc | II | Jul-18-2014 |