Product code PFQ— Clinical Chemistry

INFLAMMA DRY

Classification name: Mmp-9 Test System
Device class: Class 1
Regulation: 21 CFR 862.1540
Advisory panel: Clinical Chemistry
Total cleared: 1
First cleared: 2013-11-21
Most recent: 2013-11-21

FDA classification definition

“A visual, qualitative immunoassay for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye.”
— U.S. Food and Drug Administration, device classification record for product code PFQ under 21 CFR 862.1540, via openFDA

Market context for product code PFQ

FDA has cleared 1 device under product code PFQ, all in 2013, filed by 1 applicant company. 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.

Top applicants under product code PFQ

Rapid Pathogen Screening, Inc.1 clearance

Recent clearances under product code PFQ

K132066 — INFLAMMA DRYRapid Pathogen Screening, Inc.·2013-11-21

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