510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092655Substantially Equivalent

C. Albicans Pna Fish

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

K092655 is the FDA 510(k) clearance record for C. ALBICANS PNA FISH, a class I device, cleared for Advandx, Inc. on under FDA product code NZS (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast). FDA's definition for product code NZS reads: "Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast". FDA records list 21 510(k) clearances for Advandx, Inc., from to . As of , FDA records show no recalls naming K092655.

Clearance record

Decision date
Received
(144 days to decision)
Product code
NZS Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
Regulation
21 CFR 866.2660
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 NZS

Trailing 12 months

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

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