HY-PREP SYSTEM— 510(k) K913809

Substantially Equivalent

Hyperion, Inc.

FDA 510(k) clearance K913809 for HY-PREP SYSTEM, Substantially Equivalent on 1992-01-15. Applicant: Hyperion, Inc.. Device class: 1.

Clearance details

Applicant: Hyperion, Inc.
Product code: Code JQW
Device class: Class 1
Regulation: 21 CFR 862.2750
Advisory panel: Clinical Chemistry
Date received: 1991-08-26
Decision date: 1992-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.