C-Reactive Protein Kit for use on SPAPLUS— 510(k) K161982

Name: FDA 510(k) clearance K161982
Creator: U.S. Food and Drug Administration
Published: 2017-04-05

Substantially Equivalent

The Binding Site Group

FDA 510(k) clearance K161982 for C-Reactive Protein Kit for use on SPAPLUS, Substantially Equivalent on 2017-04-05. Applicant: The Binding Site Group. Device class: 2.

Clearance details

Applicant: The Binding Site Group
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2016-07-19
Decision date: 2017-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

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Recalls naming K161982

K-number listed on FDA's recall record

Z-1619-2020 — C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,Class II·Terminated·The Binding Site Group, Ltd.·20190425

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161982.

Data sourced from openFDA. This site is unofficial and independent of the FDA.