510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820440Substantially Equivalent

Emit-Amd Amikacin Contr. (Enzyme Immuno

Syva Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820440 is the FDA 510(k) clearance record for EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO, a class II device, cleared for Syva Co. on under FDA product code LDN (Enzymatic Radiochemical Assay, Amikacin). FDA records list 212 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K820440.

Clearance record

Decision date
Received
(26 days to decision)
Product code
LDN Enzymatic Radiochemical Assay, Amikacin
Regulation
21 CFR 862.3035
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Syva Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LDN

Trailing 12 months

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

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