AP REAGENT CARTRIDGE— 510(k) K861284

Substantially Equivalent

Hi Chem, Inc.

FDA 510(k) clearance K861284 for AP REAGENT CARTRIDGE, Substantially Equivalent on 1986-04-28. Applicant: Hi Chem, Inc.. Device class: 2.

Clearance details

Applicant: Hi Chem, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1986-04-07
Decision date: 1986-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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K960084 — HICHEM GLUCOSE/HK REAGENT KIT1996-04-04
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Data sourced from openFDA. This site is unofficial and independent of the FDA.