510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880109Substantially Equivalent

Cystine Tryptic Medium Base

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

K880109 is the FDA 510(k) clearance record for CYSTINE TRYPTIC MEDIUM BASE, a class I device, cleared for Hardy Media on under FDA product code KZI (Culture Media, Enriched). FDA records list 114 510(k) clearances for Hardy Media, from to . As of , FDA records show no recalls naming K880109.

Clearance record

Decision date
Received
(84 days to decision)
Product code
KZI Culture Media, Enriched
Regulation
21 CFR 866.2330
Device class
Class I
Review panel
Microbiology
Applicant
Hardy Media 205 W.Montecito St., Santa Barbara CA
Third party review
No

Clearances, product code KZI

Trailing 12 months

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

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