IDEIA(TM) CHLAMYDIA, MODIFICATION— 510(k) K911430

Name: FDA 510(k) clearance K911430
Creator: U.S. Food and Drug Administration
Published: 1991-08-07

Substantially Equivalent

Novo Nordisk Diagnostics, Ltd.

FDA 510(k) clearance K911430 for IDEIA(TM) CHLAMYDIA, MODIFICATION, Substantially Equivalent on 1991-08-07. Applicant: Novo Nordisk Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Novo Nordisk Diagnostics, Ltd.
Product code: Code LIC
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1991-03-28
Decision date: 1991-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge Cb4 4ws England, GB

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