HI CHEM WASH CONCENTRATE REAGENT #88805— 510(k) K890578

Name: FDA 510(k) clearance K890578
Creator: U.S. Food and Drug Administration
Published: 1989-03-10

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K890578 for HI CHEM WASH CONCENTRATE REAGENT #88805, Substantially Equivalent on 1989-03-10. Applicant: Hichem Diagnostics. Device class: 1.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code JQW
Device class: Class 1
Regulation: 21 CFR 862.2750
Advisory panel: Clinical Chemistry
Date received: 1989-02-06
Decision date: 1989-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.