DeviceClearance

Product code JOZ— Hematology

PLATELETWORKS

Classification name
System, Automated Platelet Aggregation
Device class
Class 2
Regulation
21 CFR 864.5700
Advisory panel
Hematology
Total cleared
38
First cleared
Most recent

Market context for product code JOZ

FDA has cleared 38 devices under product code JOZ between 1977 and 2020, filed by 20 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 JOZ

Recent clearances under product code JOZ

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