BUN REAGENT KIT #88108— 510(k) K800616

Substantially Equivalent

Hi Chem, Inc.

FDA 510(k) clearance K800616 for BUN REAGENT KIT #88108, Substantially Equivalent on 1980-04-10. Applicant: Hi Chem, Inc.. Device class: 2.

Clearance details

Applicant: Hi Chem, Inc.
Product code: Code CDS
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1980-03-18
Decision date: 1980-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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