510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011086Substantially Equivalent

Hardydisk Bacitracin, 10Mcg, Model Z927

Hardy Diagnostics, Santa Maria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011086 is the FDA 510(k) clearance record for HARDYDISK BACITRACIN, 10MCG, MODEL Z927, a class II device, cleared for Hardy Diagnostics on under FDA product code JTN (Susceptibility Test Discs, Antimicrobial). FDA records list 109 510(k) clearances for Hardy Diagnostics, from to . As of , FDA records show no recalls naming K011086.

Clearance record

Decision date
Received
(16 days to decision)
Product code
JTN Susceptibility Test Discs, Antimicrobial
Regulation
21 CFR 866.1620
Device class
Class II
Review panel
Microbiology
Applicant
Hardy Diagnostics 1430 W. Mccoy Ln., Santa Maria CA
510(k) summary
Statement
Third party review
No

Clearances, product code JTN

Trailing 12 months
6 clearances under product code JTN in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JTN, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20262
August 20261
September 20260
October 20260