CK-NAC REAGENT— 510(k) K974833

Substantially Equivalent

Intersect Systems, Inc.

FDA 510(k) clearance K974833 for CK-NAC REAGENT, Substantially Equivalent on 1998-02-13. Applicant: Intersect Systems, Inc.. Device class: 2.

Clearance details

Applicant: Intersect Systems, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1997-12-24
Decision date: 1998-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longview, WA, US

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