ISO-DATA 500 SERIES GAMMA COUNTER— 510(k) K872430

Name: FDA 510(k) clearance K872430
Creator: U.S. Food and Drug Administration
Published: 1987-08-21

Substantially Equivalent

Iso-Data, Inc.

FDA 510(k) clearance K872430 for ISO-DATA 500 SERIES GAMMA COUNTER, Substantially Equivalent on 1987-08-21. Applicant: Iso-Data, Inc.. Device class: 1.

Clearance details

Applicant: Iso-Data, Inc.
Product code: Code JJJ
Device class: Class 1
Regulation: 21 CFR 862.2320
Advisory panel: Clinical Chemistry
Date received: 1987-06-22
Decision date: 1987-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rolling Meadows, IL, US

Download summary PDF View on FDA.gov ↗

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