510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K160512Substantially Equivalent

HardyCHROM ESBL

Hardy Diagnostics, Santa Maria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160512 is the FDA 510(k) clearance record for HardyCHROM ESBL, a class II device, cleared for Hardy Diagnostics on under FDA product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar). FDA records list 109 510(k) clearances for Hardy Diagnostics, from to . As of , FDA records show no recalls naming K160512.

Clearance record

Decision date
Received
(265 days to decision)
Product code
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Regulation
21 CFR 866.1700
Device class
Class II
Review panel
Microbiology
Applicant
Hardy Diagnostics 1430 W. Mccou Ln., Santa Maria CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JSO

Trailing 12 months

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

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