ARCHITECT SIROLIMUS ASSAY— 510(k) K070822

Clearance details

Applicant

Fujirebio Diagnostics,Inc.

Product code

Code NRP

Device class

Class 2

Regulation

21 CFR 862.3840

Advisory panel

Clinical Toxicology

Date received

2007-03-26

Decision date

2007-09-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Malvern, PA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070822.