DUAL VIAL CREATININE REAGENT— 510(k) K983937

Name: FDA 510(k) clearance K983937
Creator: U.S. Food and Drug Administration
Published: 1999-01-06

Substantially Equivalent

Intersect Systems, Inc.

FDA 510(k) clearance K983937 for DUAL VIAL CREATININE REAGENT, Substantially Equivalent on 1999-01-06. Applicant: Intersect Systems, Inc.. Device class: 2.

Clearance details

Applicant: Intersect Systems, Inc.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1998-11-05
Decision date: 1999-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longview, WA, US

Download summary PDF View on FDA.gov ↗

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