LAS-R HUMAN PREALBUMIN TEST— 510(k) K772329

Name: FDA 510(k) clearance K772329
Creator: U.S. Food and Drug Administration
Published: 1978-02-03

Substantially Equivalent

Hyland Therapeutic Div., Travenol Laboratories

FDA 510(k) clearance K772329 for LAS-R HUMAN PREALBUMIN TEST, Substantially Equivalent on 1978-02-03. Applicant: Hyland Therapeutic Div., Travenol Laboratories. Device class: 1.

Clearance details

Applicant: Hyland Therapeutic Div., Travenol Laboratories
Product code: Code JZJ
Device class: Class 1
Regulation: 21 CFR 866.5060
Advisory panel: Immunology
Date received: 1977-12-21
Decision date: 1978-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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