HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196— 510(k) K890773

Name: FDA 510(k) clearance K890773
Creator: U.S. Food and Drug Administration
Published: 1989-04-18

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K890773 for HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196, Substantially Equivalent on 1989-04-18. Applicant: Hichem Diagnostics. Device class: 1.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
Advisory panel: Clinical Chemistry
Date received: 1989-02-15
Decision date: 1989-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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