510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PFQClass I

Mmp-9 Test System

21 CFR 862.1540 / Clinical Chemistry
FDA source (opens on fda.gov)

PFQ is the FDA product code for Mmp-9 Test System, a class I device type, regulated under 21 CFR 862.1540. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 3 recalls.

Classification record

Product code
PFQ
Device name
Mmp-9 Test System
FDA 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.
Regulation
21 CFR 862.1540
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
3

Clearances, product code PFQ

By decision year
1 clearance under product code PFQ with a decision year between 2013 and 2013, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PFQ by decision year
YearClearances
20131

Applicants with the most clearances

Product code PFQ
Applicants holding the most 510(k) clearances under product code PFQ
ApplicantClearances
Rapid Pathogen Screening, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code