510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K820324Substantially Equivalent

Emit and Netilmicin Assay

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

K820324 is the FDA 510(k) clearance record for EMIT AND NETILMICIN ASSAY, a class II device, cleared for Syva Co. on under FDA product code LCE (Radioimmunoassay, Netilmicin (I-125)). FDA records list 212 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K820324.

Clearance record

Decision date
Received
(18 days to decision)
Product code
LCE Radioimmunoassay, Netilmicin (I-125)
Regulation
21 CFR 862.3450
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 LCE

Trailing 12 months

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

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