AUTOMATED ENZYME— 510(k) K780962

Name: FDA 510(k) clearance K780962
Creator: U.S. Food and Drug Administration
Published: 1978-07-27

Substantially Equivalent

Hyland Therapeutic Div., Travenol Laboratories

FDA 510(k) clearance K780962 for AUTOMATED ENZYME, Substantially Equivalent on 1978-07-27. Applicant: Hyland Therapeutic Div., Travenol Laboratories. Device class: 2.

Clearance details

Applicant: Hyland Therapeutic Div., Travenol Laboratories
Product code: Code KSK
Device class: Class 2
Regulation: 21 CFR 864.9400
Advisory panel: Hematology
Date received: 1978-06-12
Decision date: 1978-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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