HI CHEM CALCIUM REAGENT #88808— 510(k) K890584

Name: FDA 510(k) clearance K890584
Creator: U.S. Food and Drug Administration
Published: 1989-04-10

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K890584 for HI CHEM CALCIUM REAGENT #88808, Substantially Equivalent on 1989-04-10. Applicant: Hichem Diagnostics. Device class: 2.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code CJY
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1989-02-06
Decision date: 1989-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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