HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)— 510(k) K090920

Clearance details

Applicant

The Binding Site, Ltd.

Product code

Code CFN

Device class

Class 2

Regulation

21 CFR 866.5510

Advisory panel

Immunology

Date received

2009-04-01

Decision date

2009-12-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Santa Monica, CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090920.