OVEIA (TM) DUAL ANALYTE— 510(k) K872843

Name: FDA 510(k) clearance K872843
Creator: U.S. Food and Drug Administration
Published: 1988-02-02

Substantially Equivalent

Boots-Celltech Diagnostics, Inc.

FDA 510(k) clearance K872843 for OVEIA (TM) DUAL ANALYTE, Substantially Equivalent on 1988-02-02. Applicant: Boots-Celltech Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Boots-Celltech Diagnostics, Inc.
Product code: Code JLP
Device class: Class 1
Regulation: 21 CFR 862.1605
Advisory panel: Clinical Chemistry
Date received: 1987-07-20
Decision date: 1988-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkshire, England, GB

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