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
K113371Substantially Equivalent

Staphylococcus Quickfish Bc

Advandx, Inc., Woburn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K113371 is the FDA 510(k) clearance record for STAPHYLOCOCCUS QUICKFISH BC, a class I device, cleared for Advandx, Inc. on under FDA product code NXX (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus). FDA's definition for product code NXX reads: "The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr...". FDA records list 21 510(k) clearances for Advandx, Inc., from to . As of , FDA records show one recall naming K113371.

Clearance record

Decision date
Received
(139 days to decision)
Product code
NXX Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Regulation
21 CFR 866.3700
Device class
Class I
Review panel
Microbiology
Applicant
Advandx, Inc. 400 Tradecenter Suite 6990, Woburn MA
510(k) summary
Statement
Third party review
No

Clearances, product code NXX

Trailing 12 months

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

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