510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833207Substantially Equivalent

Ak Agar 2

Neogen Culture Media, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833207 is the FDA 510(k) clearance record for AK AGAR 2, a class II device, cleared for Acumedia Manufacturers, Inc. on under FDA product code LKA (Culture Media, Antimicrobial Susceptibility Test). FDA records list 177 510(k) clearances for Neogen Culture Media, from to . As of , FDA records show no recalls naming K833207.

Clearance record

Decision date
Received
(38 days to decision)
Product code
LKA Culture Media, Antimicrobial Susceptibility Test
Regulation
21 CFR 866.1700
Device class
Class II
Review panel
Microbiology
Applicant
Acumedia Manufacturers, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LKA

Trailing 12 months

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

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