510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880511Substantially Equivalent

Xact Neisseria

Austin Biological Laboratories, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880511 is the FDA 510(k) clearance record for XACT NEISSERIA, a class I device, cleared for Austin Biological Laboratories on under FDA product code JSX (Kit, Identification, Neisseria Gonorrhoeae). FDA records list 45 510(k) clearances for Austin Biological Laboratories, from to . As of , FDA records show no recalls naming K880511.

Clearance record

Decision date
Received
(198 days to decision)
Product code
JSX Kit, Identification, Neisseria Gonorrhoeae
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Austin Biological Laboratories 6620-A Manor Rd., Austin TX
Third party review
No

Clearances, product code JSX

Trailing 12 months

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

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