NRP · Class II · 21 CFR 862.3840

FDA Product Code NRP: Sirolimus Test System

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.

Leading manufacturers include Siemens Healthcare Diagnostics, Inc..

Total

Cleared

137d

Avg days

2004

Since

FDA 510(k) Cleared Sirolimus Test System Devices (Product Code NRP)

5 devices

1–5 of 5

Cleared Oct 30, 2008

DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306

K081857

Siemens Healthcare Diagnostics, Inc.

Toxicology · 121d

About Product Code NRP - Regulatory Context

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Data Source

FDA 510(k) public files . 175,450 total devices indexed.

Latest clearance: Mar 30, 2009

Product Code Info

Code	NRP
Device class	Class II
CFR	21 CFR 862.3840
Panel	Toxicology

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