CALIBRATION REFERENCE I & II— 510(k) K855035

Name: FDA 510(k) clearance K855035
Creator: U.S. Food and Drug Administration
Published: 1986-03-17

Substantially Equivalent

Integrated Medical Systems Int'L., Inc.

FDA 510(k) clearance K855035 for CALIBRATION REFERENCE I & II, Substantially Equivalent on 1986-03-17. Applicant: Integrated Medical Systems Int'L., Inc.. Device class: 1.

Clearance details

Applicant: Integrated Medical Systems Int'L., Inc.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1985-12-17
Decision date: 1986-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mc Allen, TX, US

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