AMYLASE REAGENT #88129— 510(k) K831295

Substantially Equivalent

Hi Chem, Inc.

FDA 510(k) clearance K831295 for AMYLASE REAGENT #88129, Substantially Equivalent on 1983-06-30. Applicant: Hi Chem, Inc..

Clearance details

Applicant: Hi Chem, Inc.
Product code: Code KHM
Advisory panel: Clinical Chemistry
Date received: 1983-04-20
Decision date: 1983-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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