DIRECT BILIRUBIN— 510(k) K930679

Substantially Equivalent

Horizon Diagnostics, Inc.

FDA 510(k) clearance K930679 for DIRECT BILIRUBIN, Substantially Equivalent on 1993-06-29. Applicant: Horizon Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Horizon Diagnostics, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1993-02-09
Decision date: 1993-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jackson, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.