D.A.T. (TM) AMYLASE REAGENT— 510(k) K871943

Name: FDA 510(k) clearance K871943
Creator: U.S. Food and Drug Administration
Published: 1987-06-03

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K871943 for D.A.T. (TM) AMYLASE REAGENT, Substantially Equivalent on 1987-06-03. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code CIJ
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1987-05-19
Decision date: 1987-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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