510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010871Substantially Equivalent

Tgl Flex Reagent Cartridge

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

K010871 is the FDA 510(k) clearance record for TGL FLEX REAGENT CARTRIDGE, a class I device, cleared for Dade Behring, Inc. on under FDA product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show one recall naming K010871.

Clearance record

Decision date
Received
(108 days to decision)
Product code
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Regulation
21 CFR 862.1705
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Dade Behring, Inc. 514 Gbc Dr., Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code CDT

Trailing 12 months

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

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