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

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.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code CJA
Advisory panel: Clinical Chemistry
Date received: 1989-09-06
Decision date: 1989-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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