AMYLASE REAGENT SET— 510(k) K790797

Substantially Equivalent

Alta Diagnostics, Inc.

FDA 510(k) clearance K790797 for AMYLASE REAGENT SET, Substantially Equivalent on 1979-07-17. Applicant: Alta Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Alta Diagnostics, Inc.
Product code: Code KHM
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1979-04-24
Decision date: 1979-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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