A-QC CLINICAL CHEMISTRY CONTROL— 510(k) K873611

Name: FDA 510(k) clearance K873611
Creator: U.S. Food and Drug Administration
Published: 1987-10-20

Substantially Equivalent

Arden Medical Systems, Inc.

FDA 510(k) clearance K873611 for A-QC CLINICAL CHEMISTRY CONTROL, Substantially Equivalent on 1987-10-20. Applicant: Arden Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Arden Medical Systems, Inc.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1987-09-08
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, MN, US

Download summary PDF View on FDA.gov ↗

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