510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853684Substantially Equivalent

Precept Kanamycin

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

K853684 is the FDA 510(k) clearance record for PRECEPT KANAMYCIN, a class II device, cleared for Austin Biological Laboratories on under FDA product code LTW (Susceptibility Test Cards, Antimicrobial). FDA records list 45 510(k) clearances for Austin Biological Laboratories, from to . As of , FDA records show no recalls naming K853684.

Clearance record

Decision date
Received
(175 days to decision)
Product code
LTW Susceptibility Test Cards, Antimicrobial
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Austin Biological Laboratories 6620-A Manor Rd., Austin TX
Third party review
No

Clearances, product code LTW

Trailing 12 months

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

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