OSMOTIC PRESSURE AUTO & STAT OM-6010— 510(k) K842750

Name: FDA 510(k) clearance K842750
Creator: U.S. Food and Drug Administration
Published: 1984-08-17

Substantially Equivalent

Kyoto Diagnostics, Inc.

FDA 510(k) clearance K842750 for OSMOTIC PRESSURE AUTO & STAT OM-6010, Substantially Equivalent on 1984-08-17. Applicant: Kyoto Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Kyoto Diagnostics, Inc.
Product code: Code JJM
Device class: Class 1
Regulation: 21 CFR 862.2730
Advisory panel: Clinical Chemistry
Date received: 1984-07-13
Decision date: 1984-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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