510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K081643Substantially Equivalent

Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, Rf621, Kd692

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

K081643 is the FDA 510(k) clearance record for DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692, a class II device, cleared for Siemens Healthcare Diagnostics on under FDA product code MMI (Immunoassay Method, Troponin Subunit). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, from to . As of , FDA records show 4 recalls naming K081643.

Clearance record

Decision date
Received
(21 days to decision)
Product code
MMI Immunoassay Method, Troponin Subunit
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Siemens Healthcare Diagnostics Ms 514, P.O. Box 6101, Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MMI

Trailing 12 months
1 clearance under product code MMI in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MMI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260