510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864802Substantially Equivalent

Dart Digoxin Assay

Coulter Electronics, Inc., Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864802 is the FDA 510(k) clearance record for DART DIGOXIN ASSAY, a class II device, cleared for Coulter Electronics, Inc. on under FDA product code LCS (Radioimmunoassay, Digoxin (125-I)). FDA records list 101 510(k) clearances for Coulter Electronics, Inc., from to . As of , FDA records show no recalls naming K864802.

Clearance record

Decision date
Received
(65 days to decision)
Product code
LCS Radioimmunoassay, Digoxin (125-I)
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Coulter Electronics, Inc. 440 W. 20 St., Hialeah FL
Third party review
No

Clearances, product code LCS

Trailing 12 months

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

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