VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM— 510(k) K880437

Name: FDA 510(k) clearance K880437
Creator: U.S. Food and Drug Administration
Published: 1988-08-03

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K880437 for VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM, Substantially Equivalent on 1988-08-03. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1988-02-02
Decision date: 1988-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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