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

Sirolimus Test System

21 CFR 862.3840 / Clinical Toxicology
FDA source (opens on fda.gov)

NRP is the FDA product code for Sirolimus Test System, a class II device type, regulated under 21 CFR 862.3840. FDA's definition for this code 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". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
NRP
Device name
Sirolimus Test System
FDA definition
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.
Regulation
21 CFR 862.3840
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
6

Clearances, product code NRP

By decision year
5 clearances under product code NRP with a decision year between 2004 and 2009, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NRP by decision year
YearClearances
20041
20051
20071
20081
20091

Applicants with the most clearances

Product code NRP
Applicants holding the most 510(k) clearances under product code NRP
ApplicantClearances
Siemens Healthcare Diagnostics Inc.2
Axis-Shield, Ltd.1
Fujirebio Diagnostics, Inc.1
Microgenics Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code