HI CHEM CREATININE REAGENT (PRODUCT #88809)— 510(k) K890671

Name: FDA 510(k) clearance K890671
Creator: U.S. Food and Drug Administration
Published: 1989-05-09

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K890671 for HI CHEM CREATININE REAGENT (PRODUCT #88809), Substantially Equivalent on 1989-05-09. Applicant: Hichem Diagnostics. Device class: 2.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1989-02-09
Decision date: 1989-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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