DeviceClearance

Product code CIN— Clinical Chemistry

ALKPHASE-B ASSAY KIT

Classification name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device class
Class 2
Regulation
21 CFR 862.1050
Advisory panel
Clinical Chemistry
Total cleared
26
First cleared
Most recent

Market context for product code CIN

FDA has cleared 26 devices under product code CIN between 1976 and 2024, filed by 18 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

last 15 years

Top applicants under product code CIN

Recent clearances under product code CIN

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