CARESIDE CALCIUM, ORIGINAL— 510(k) K983789

Substantially Equivalent

Careside, Inc.

FDA 510(k) clearance K983789 for CARESIDE CALCIUM, ORIGINAL, Substantially Equivalent on 1998-12-17. Applicant: Careside, Inc.. Device class: 2.

Clearance details

Applicant: Careside, Inc.
Product code: Code CJY
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1998-10-27
Decision date: 1998-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, 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.