BIOCLONES ELEGANCE LH ELISA KIT— 510(k) K904387

Name: FDA 510(k) clearance K904387
Creator: U.S. Food and Drug Administration
Published: 1990-11-06

Substantially Equivalent

Bioclone Australia Pty , Ltd.

FDA 510(k) clearance K904387 for BIOCLONES ELEGANCE LH ELISA KIT, Substantially Equivalent on 1990-11-06. Applicant: Bioclone Australia Pty , Ltd.. Device class: 1.

Clearance details

Applicant: Bioclone Australia Pty , Ltd.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1990-09-25
Decision date: 1990-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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