HICHEM ION 2/4 SERUM RANGE CALIBRATOR— 510(k) K842449

Name: FDA 510(k) clearance K842449
Creator: U.S. Food and Drug Administration
Published: 1984-08-16

Substantially Equivalent

Hi Chem, Inc.

FDA 510(k) clearance K842449 for HICHEM ION 2/4 SERUM RANGE CALIBRATOR, Substantially Equivalent on 1984-08-16. Applicant: Hi Chem, Inc.. Device class: 2.

Clearance details

Applicant: Hi Chem, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1984-06-22
Decision date: 1984-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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