ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082— 510(k) K823756

Name: FDA 510(k) clearance K823756
Creator: U.S. Food and Drug Administration
Published: 1983-01-12

Substantially Equivalent

Em Industries, Inc.

FDA 510(k) clearance K823756 for ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082, Substantially Equivalent on 1983-01-12. Applicant: Em Industries, Inc.. Device class: 2.

Clearance details

Applicant: Em Industries, Inc.
Product code: Code CIC
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1982-12-14
Decision date: 1983-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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