COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER— 510(k) K855149

Name: FDA 510(k) clearance K855149
Creator: U.S. Food and Drug Administration
Published: 1986-02-11

Substantially Equivalent

Hyperion, Inc.

FDA 510(k) clearance K855149 for COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER, Substantially Equivalent on 1986-02-11. Applicant: Hyperion, Inc.. Device class: 1.

Clearance details

Applicant: Hyperion, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1985-12-26
Decision date: 1986-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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K913809 — HY-PREP SYSTEM1992-01-15
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