NGD · Test, Lactic Acid, Over The Counter
Clinical Chemistry · 21 CFR 862.1450 · Class 1
Overview
| Product Code | NGD |
|---|---|
| Device Name | Test, Lactic Acid, Over The Counter |
| Regulation | 21 CFR 862.1450 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
