GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)— 510(k) K861893

Name: FDA 510(k) clearance K861893
Creator: U.S. Food and Drug Administration
Published: 1986-06-05

Substantially Equivalent

Hi Chem, Inc.

FDA 510(k) clearance K861893 for GGT REAGENT CARTRIDGE (PRODUCT NO. 88204), Substantially Equivalent on 1986-06-05. Applicant: Hi Chem, Inc.. Device class: 2.

Clearance details

Applicant: Hi Chem, Inc.
Product code: Code JXL
Device class: Class 2
Regulation: 21 CFR 882.5070
Advisory panel: Neurology
Date received: 1986-05-16
Decision date: 1986-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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