510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101558Substantially Equivalent

Gnr Traffic Light Pna Fish

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

K101558 is the FDA 510(k) clearance record for GNR TRAFFIC LIGHT PNA FISH, a class I device, cleared for Advandx, Inc. on under FDA product code JSS (Kit, Identification, Enterobacteriaceae). FDA records list 21 510(k) clearances for Advandx, Inc., from to . As of , FDA records show no recalls naming K101558.

Clearance record

Decision date
Received
(195 days to decision)
Product code
JSS Kit, Identification, Enterobacteriaceae
Regulation
21 CFR 866.2660
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 JSS

Trailing 12 months

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

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