510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781495Substantially Equivalent

Rianen Assay System, 125I Kit

New England Nuclear, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781495 is the FDA 510(k) clearance record for RIANEN ASSAY SYSTEM, 125I KIT, a class II device, cleared for New England Nuclear on under FDA product code DNL (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.). FDA records list 18 510(k) clearances for New England Nuclear, from to . As of , FDA records show no recalls naming K781495.

Clearance record

Decision date
Received
(15 days to decision)
Product code
DNL Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
New England Nuclear 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DNL

Trailing 12 months

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

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