AMYLASE REAGENT SET-MODIFIED CARAWAY— 510(k) K833864

Name: FDA 510(k) clearance K833864
Creator: U.S. Food and Drug Administration
Published: 1984-01-13

Substantially Equivalent

Sterling Biochemical, Inc.

FDA 510(k) clearance K833864 for AMYLASE REAGENT SET-MODIFIED CARAWAY, Substantially Equivalent on 1984-01-13. Applicant: Sterling Biochemical, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Biochemical, Inc.
Product code: Code CJA
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1983-11-07
Decision date: 1984-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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