REAGENT KIT, ENZYMATIC AMYLASE— 510(k) K770750

Name: FDA 510(k) clearance K770750
Creator: U.S. Food and Drug Administration
Published: 1977-07-05

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K770750 for REAGENT KIT, ENZYMATIC AMYLASE, Substantially Equivalent on 1977-07-05. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code JFJ
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1977-04-25
Decision date: 1977-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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