510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012301Substantially Equivalent

Immulite 2000 Digoxin, Models L2kdi2 (200 Tests) and L2kdi6 (600 Tests)

Siemens Healthcare Diagnostics Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012301 is the FDA 510(k) clearance record for IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS), a class II device, cleared for Diagnostic Products Corp. on under FDA product code KXT (Enzyme Immunoassay, Digoxin). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K012301.

Clearance record

Decision date
Received
(61 days to decision)
Product code
KXT Enzyme Immunoassay, Digoxin
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
510(k) summary
Summary
Third party review
No

Clearances, product code KXT

Trailing 12 months

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

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