DeviceClearance

Product code KLP— Clinical Toxicology

BACTEC

Classification name
Amikacin Serum Assay
Device class
Class 2
Regulation
21 CFR 862.3035
Advisory panel
Clinical Toxicology
Total cleared
4
First cleared
Most recent

Market context for product code KLP

FDA has cleared 4 devices under product code KLP between 1978 and 2003, filed by 4 applicant companies. 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.

Clearances per year

Top applicants under product code KLP

Recent clearances under product code KLP

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