510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150168Substantially Equivalent

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

Siemens Healthcare Diagnostics Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150168 is the FDA 510(k) clearance record for Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL), a class II device, cleared for Siemens Healthcare Diagnostics on under FDA product code MLM (Enzyme Immunoassay, Tracrolimus). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, from to . As of , FDA records show 2 recalls naming K150168.

Clearance record

Decision date
Received
(282 days to decision)
Product code
MLM Enzyme Immunoassay, Tracrolimus
Regulation
21 CFR 862.1678
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Siemens Healthcare Diagnostics 500 Gbc Dr., Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MLM

Trailing 12 months

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

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