DeviceClearance

Product code CER— Clinical Chemistry

ELVI TOTAL PROTEINS

Classification name
2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase
Device class
Class 2
Regulation
21 CFR 862.1440
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

Market context for product code CER

FDA has cleared 1 device under product code CER, all in 1979, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code CER

Recent clearances under product code CER

Data sourced from openFDA. This site is unofficial and independent of the FDA.