DeviceClearance

Product code PPM— Pathology

0.85% SALINE

Classification name
General Purpose Reagent
Device class
Class 1
Regulation
21 CFR 864.4010
Advisory panel
Pathology
Total cleared
16
First cleared
Most recent

FDA classification definition

“A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.”

— U.S. Food and Drug Administration, device classification record for product code PPM under 21 CFR 864.4010, via openFDA

Market context for product code PPM

FDA has cleared 16 devices under product code PPM between 1981 and 1987, 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 PPM

Recent clearances under product code PPM

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