SELISA ANTI-N DNA ANTIBODIES— 510(k) K940585

Name: FDA 510(k) clearance K940585
Creator: U.S. Food and Drug Administration
Published: 1994-06-10

Substantially Equivalent

Cambridge Life Sciences Plc.

FDA 510(k) clearance K940585 for SELISA ANTI-N DNA ANTIBODIES, Substantially Equivalent on 1994-06-10. Applicant: Cambridge Life Sciences Plc.. Device class: 2.

Clearance details

Applicant: Cambridge Life Sciences Plc.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1994-02-08
Decision date: 1994-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ely, Cambridgeshire, GB

Download summary PDF View on FDA.gov ↗

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