ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA— 510(k) K901972

Name: FDA 510(k) clearance K901972
Creator: U.S. Food and Drug Administration
Published: 1990-09-05

Substantially Equivalent

Novo Nordisk Diagnostics, Ltd.

FDA 510(k) clearance K901972 for ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA, Substantially Equivalent on 1990-09-05. Applicant: Novo Nordisk Diagnostics, Ltd.. Device class: 1.

Clearance details

Applicant: Novo Nordisk Diagnostics, Ltd.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1990-05-01
Decision date: 1990-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge Cb4 4ws England, GB

Download summary PDF View on FDA.gov ↗

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