DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)— 510(k) K896582

Name: FDA 510(k) clearance K896582
Creator: U.S. Food and Drug Administration
Published: 1990-06-28

Substantially Equivalent

Primus, Inc.

FDA 510(k) clearance K896582 for DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM), Substantially Equivalent on 1990-06-28. Applicant: Primus, Inc.. Device class: 2.

Clearance details

Applicant: Primus, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1989-11-17
Decision date: 1990-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.