DeviceClearance

Product code JMM— Clinical Chemistry

PYRILINKS-D ASSAY KIT

Classification name
Column Chromatography & Color Development, Hydroxyproline
Device class
Class 1
Regulation
21 CFR 862.1400
Advisory panel
Clinical Chemistry
Total cleared
21
First cleared
Most recent

Market context for product code JMM

FDA has cleared 21 devices under product code JMM between 1977 and 2001, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code JMM

Recent clearances under product code JMM

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