DeviceClearance

Product code LCH— Clinical Chemistry

AMR RESEARCH TONOMETER

Classification name
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Device class
Class 1
Regulation
21 CFR 862.1660
Advisory panel
Clinical Chemistry
Total cleared
9
First cleared
Most recent

Market context for product code LCH

FDA has cleared 9 devices under product code LCH between 1978 and 1992, filed by 9 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 LCH

Recent clearances under product code LCH

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