SERALYZER AST/SGOT REAGENT STRIPS— 510(k) K832790

Name: FDA 510(k) clearance K832790
Creator: U.S. Food and Drug Administration
Published: 1983-10-14

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K832790 for SERALYZER AST/SGOT REAGENT STRIPS, Substantially Equivalent on 1983-10-14. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code CIF
Device class: Class 2
Regulation: 21 CFR 862.1100
Advisory panel: Clinical Chemistry
Date received: 1983-08-16
Decision date: 1983-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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