ALERT A,HDL-APOLIPOROTEIN A, TEST KIT— 510(k) K802610

Name: FDA 510(k) clearance K802610
Creator: U.S. Food and Drug Administration
Published: 1981-01-05

Substantially Equivalent

Hyland Therapeutic Div., Travenol Laboratories

FDA 510(k) clearance K802610 for ALERT A,HDL-APOLIPOROTEIN A, TEST KIT, Substantially Equivalent on 1981-01-05. Applicant: Hyland Therapeutic Div., Travenol Laboratories. Device class: 2.

Clearance details

Applicant: Hyland Therapeutic Div., Travenol Laboratories
Product code: Code DER
Device class: Class 2
Regulation: 21 CFR 866.5580
Advisory panel: Immunology
Date received: 1980-10-21
Decision date: 1981-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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