510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081857Substantially Equivalent

Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models Dr 306, Dc 306

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

K081857 is the FDA 510(k) clearance record for DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306, a class II device, cleared for Siemens Healthcare Diagnostics, Inc. on under FDA product code NRP (Sirolimus Test System). FDA's definition for product code NRP reads: "Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus". FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, Inc., from to . As of , FDA records show 2 recalls naming K081857.

Clearance record

Decision date
Received
(121 days to decision)
Product code
NRP Sirolimus Test System
Regulation
21 CFR 862.3840
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Siemens Healthcare Diagnostics, Inc. P.O. Box 6101, Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NRP

Trailing 12 months

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

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