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
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K132066Substantially Equivalent

Inflamma Dry

Rapid Pathogen Screening, Inc., Sarasota FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132066 is the FDA 510(k) clearance record for INFLAMMA DRY, a class I device, cleared for Rapid Pathogen Screening, Inc. on under FDA product code PFQ (Mmp-9 Test System). FDA's definition for product code PFQ 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". FDA records list 3 510(k) clearances for Rapid Pathogen Screening, Inc., from to . As of , FDA records show 3 recalls naming K132066.

Clearance record

Decision date
Received
(141 days to decision)
Product code
PFQ Mmp-9 Test System
Regulation
21 CFR 862.1540
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Rapid Pathogen Screening, Inc. 7227 Delainey Ct., Sarasota FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFQ

Trailing 12 months

FDA records hold no clearances under product code PFQ in the trailing twelve months.

FDA records show no clearances under product code PFQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260