Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator— 510(k) K150412

Name: FDA 510(k) clearance K150412
Creator: U.S. Food and Drug Administration
Published: 2015-08-28

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K150412 for Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator, Substantially Equivalent on 2015-08-28. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code DAE
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 2015-02-18
Decision date: 2015-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

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K974111 — QUIDEL CH50 EQ EIA1998-07-29
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K951639 — COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)1995-10-13

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