510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841161Substantially Equivalent

Immpulse Amikacin Assay Reagents

Paragon Diagnostics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841161 is the FDA 510(k) clearance record for IMMPULSE AMIKACIN ASSAY REAGENTS, a class II device, cleared for Paragon Diagnostics, Inc. on under FDA product code KLQ (Radioimmunoassay, Amikacin). FDA records list 7 510(k) clearances for Paragon Diagnostics, Inc., from to . As of , FDA records show no recalls naming K841161.

Clearance record

Decision date
Received
(44 days to decision)
Product code
KLQ Radioimmunoassay, Amikacin
Regulation
21 CFR 862.3035
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Paragon Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KLQ

Trailing 12 months

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

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