HYPERION VISIQUANT ANA TEST KIT— 510(k) K013213

Substantially Equivalent

Hyperion, Inc.

FDA 510(k) clearance K013213 for HYPERION VISIQUANT ANA TEST KIT, Substantially Equivalent on 2002-06-04. Applicant: Hyperion, Inc.. Device class: 2.

Clearance details

Applicant: Hyperion, Inc.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2001-09-26
Decision date: 2002-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Hyperion, Inc.

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K873138 — MICRO-READER II1987-09-14
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Data sourced from openFDA. This site is unofficial and independent of the FDA.