510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K070822Substantially Equivalent

Architect Sirolimus Assay

Fujirebio Diagnostics, Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070822 is the FDA 510(k) clearance record for ARCHITECT SIROLIMUS ASSAY, a class II device, cleared for Fujirebio 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 45 510(k) clearances for Fujirebio Diagnostics,Inc., from to . As of , FDA records show 2 recalls naming K070822.

Clearance record

Decision date
Received
(186 days to decision)
Product code
NRP Sirolimus Test System
Regulation
21 CFR 862.3840
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Fujirebio Diagnostics,Inc. 201 Great Valley Pkwy., Malvern PA
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