DeviceClearance

Product code CKB— Clinical Chemistry

ACID PHOSPHATASE REAGENT

Classification name
Acid Phosphatase, Naphthyl Phosphate
Device class
Class 2
Regulation
21 CFR 862.1020
Advisory panel
Clinical Chemistry
Total cleared
24
First cleared
Most recent

Market context for product code CKB

FDA has cleared 24 devices under product code CKB between 1982 and 2006, filed by 22 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 CKB

Recent clearances under product code CKB

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