LKAClass II

Culture Media, Antimicrobial Susceptibility Test

21 CFR 866.1700 / Microbiology

LKA is the FDA product code for Culture Media, Antimicrobial Susceptibility Test, a class II device type, regulated under 21 CFR 866.1700. As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 1987-08-11, and 5 recalls.

Classification record

Product code: LKA
Device name: Culture Media, Antimicrobial Susceptibility Test
Regulation: 21 CFR 866.1700
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 5
Ingested recalls: 5

Clearances, product code LKA

By decision year

5 clearances under product code LKA with a decision year between 1983 and 1987, 1987 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code LKA by decision year
Year	Clearances
1983	2
1987	3

Applicants with the most clearances

Product code LKA

Applicants holding the most 510(k) clearances under product code LKA
Applicant	Clearances
I.A.F. Production, Inc.	3
Neogen Culture Media	2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LKA.