510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990251Substantially Equivalent

Dgtx Flex Reagent Cartridge, Model Df36

Siemens Healthcare Diagnostics Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990251 is the FDA 510(k) clearance record for DGTX FLEX REAGENT CARTRIDGE, MODEL DF36, a class II device, cleared for Dade Behring, Inc. on under FDA product code LFM (Enzyme Immunoassay, Digitoxin). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K990251.

Clearance record

Decision date
Received
(63 days to decision)
Product code
LFM Enzyme Immunoassay, Digitoxin
Regulation
21 CFR 862.3300
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Dade Behring, Inc. Bldg. 500 Mail Box 514, Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code LFM

Trailing 12 months

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

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