Human IgM Kit for use on SPAPlus— 510(k) K191465

Name: FDA 510(k) clearance K191465
Creator: U.S. Food and Drug Administration
Published: 2019-06-27

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K191465 for Human IgM Kit for use on SPAPlus, Substantially Equivalent on 2019-06-27. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2019-06-03
Decision date: 2019-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Edgbaston, GB

Download summary PDF View on FDA.gov ↗

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Recalls naming K191465

K-number listed on FDA's recall record

Z-1327-2020 — OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565Class II·Terminated·The Binding Site Group, Ltd.·20190729

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191465.

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