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
K110722Substantially Equivalent

Rps Adeno Detector Plus

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

K110722 is the FDA 510(k) clearance record for RPS ADENO DETECTOR PLUS, a class I device, cleared for Rapid Pathogen Screening, Inc. on under FDA product code GOD (Antigens, Cf (Including Cf Control), Adenovirus 1-33). FDA records list 3 510(k) clearances for Rapid Pathogen Screening, Inc., from to . As of , FDA records show no recalls naming K110722.

Clearance record

Decision date
Received
(63 days to decision)
Product code
GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33
Regulation
21 CFR 866.3020
Device class
Class I
Review panel
Microbiology
Applicant
Rapid Pathogen Screening, Inc. 7227 Delainey Ct., Sarasota FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GOD

Trailing 12 months

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

FDA records show no clearances under product code GOD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GOD, 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