SERALYZER HEMOGLOBIN REAGENT STRIPS— 510(k) K822044

Name: FDA 510(k) clearance K822044
Creator: U.S. Food and Drug Administration
Published: 1982-07-30

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K822044 for SERALYZER HEMOGLOBIN REAGENT STRIPS, Substantially Equivalent on 1982-07-30. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1982-07-12
Decision date: 1982-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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