510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083074Substantially Equivalent

Avandx E. Faecalis/oe Pna Fish Culture Identification Kit

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

K083074 is the FDA 510(k) clearance record for AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT, a class I device, cleared for Advandx, Inc. on under FDA product code OAH (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis). FDA's definition for product code OAH reads: "E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains". FDA records list 21 510(k) clearances for Advandx, Inc., from to . As of , FDA records show one recall naming K083074.

Clearance record

Decision date
Received
(282 days to decision)
Product code
OAH Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Advandx, Inc. 10a Roessler Rd., Woburn MA
510(k) summary
Statement
Third party review
No

Clearances, product code OAH

Trailing 12 months

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

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