MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)— 510(k) K895555

Name: FDA 510(k) clearance K895555
Creator: U.S. Food and Drug Administration
Published: 1989-12-22

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K895555 for MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129), Substantially Equivalent on 1989-12-22. Applicant: Hichem Diagnostics. Device class: 2.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code CJA
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1989-09-06
Decision date: 1989-12-22
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.