DIMENSION(R) LACTIC ACID METHOD
Device Facts
| Record ID | K914508 |
|---|---|
| Device Name | DIMENSION(R) LACTIC ACID METHOD |
| Applicant | E.I. Dupont DE Nemours & Co., Inc. |
| Product Code | KHP · Clinical Chemistry |
| Decision Date | Nov 27, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1450 |
| Device Class | Class 1 |
Regulatory Classification
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).
