KZIClass I

Culture Media, Enriched

21 CFR 866.2330 / Microbiology

KZI is the FDA product code for Culture Media, Enriched, a class I device type, regulated under 21 CFR 866.2330. As of 2026-09-10, FDA records hold 51 510(k) clearances under this code, the most recent dated 1988-10-25, and 2 recalls.

Classification record

Product code: KZI
Device name: Culture Media, Enriched
Regulation: 21 CFR 866.2330
Device class: Class I
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 51
Ingested recalls: 2

Clearances, product code KZI

By decision year

51 clearances under product code KZI with a decision year between 1982 and 1988, 1987 the highest year at 18.

Show the numbers

510(k) clearances under FDA product code KZI by decision year
Year	Clearances
1982	1
1983	4
1984	6
1985	9
1986	4
1987	18
1988	9

Applicants with the most clearances

Product code KZI

Applicants holding the most 510(k) clearances under product code KZI
Applicant	Clearances
Hardy Media	9
Lakewood Biochemical Co., Inc.	6
Otisville Biotech, Inc.	4
BD Becton Dickinson Vacutainer Systems Preanalytic	3
I.A.F. Production, Inc.	3
Microline Scientific	3
bioMerieux, Inc.	3
Apl Medical Supplies	2
Central Media	2
Gibco Laboratories Life Technologies, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order