DeviceClearance

Product code CIW— Clinical Chemistry

AMYLASE TEST (AMYL) ITEM NUMBER: 65653

Classification name
Starch-Dye Bound Polymer, Amylase
Device class
Class 2
Regulation
21 CFR 862.1070
Advisory panel
Clinical Chemistry
Total cleared
8
First cleared
Most recent

Market context for product code CIW

FDA has cleared 8 devices under product code CIW between 1979 and 1993, filed by 8 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 CIW

Recent clearances under product code CIW

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