LAS-R HUMAN C1 ESTERASE INHIBITOR TEST— 510(k) K780335

Name: FDA 510(k) clearance K780335
Creator: U.S. Food and Drug Administration
Published: 1978-03-22

Substantially Equivalent

Hyland Therapeutic Div., Travenol Laboratories

FDA 510(k) clearance K780335 for LAS-R HUMAN C1 ESTERASE INHIBITOR TEST, Substantially Equivalent on 1978-03-22. Applicant: Hyland Therapeutic Div., Travenol Laboratories. Device class: 2.

Clearance details

Applicant: Hyland Therapeutic Div., Travenol Laboratories
Product code: Code DBA
Device class: Class 2
Regulation: 21 CFR 866.5250
Advisory panel: Immunology
Date received: 1978-02-28
Decision date: 1978-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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