DIRECT BILIRUBIN REAGENT— 510(k) K841572

Substantially Equivalent

Hi Chem, Inc.

FDA 510(k) clearance K841572 for DIRECT BILIRUBIN REAGENT, Substantially Equivalent on 1984-05-16. Applicant: Hi Chem, Inc.. Device class: 2.

Clearance details

Applicant: Hi Chem, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1984-04-17
Decision date: 1984-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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