MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST— 510(k) K872056

Name: FDA 510(k) clearance K872056
Creator: U.S. Food and Drug Administration
Published: 1987-06-15

Substantially Equivalent

Boots-Celltech Diagnostics, Inc.

FDA 510(k) clearance K872056 for MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST, Substantially Equivalent on 1987-06-15. Applicant: Boots-Celltech Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Boots-Celltech Diagnostics, Inc.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1987-05-28
Decision date: 1987-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkshire, England, GB

Download summary PDF View on FDA.gov ↗

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