SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH)— 510(k) K801665

Name: FDA 510(k) clearance K801665
Creator: U.S. Food and Drug Administration
Published: 1980-08-20

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K801665 for SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH), Substantially Equivalent on 1980-08-20. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1980-07-21
Decision date: 1980-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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