URINE/CSF MICROPROTEIN REAGENT— 510(k) K913225

Name: FDA 510(k) clearance K913225
Creator: U.S. Food and Drug Administration
Published: 1991-10-11

Substantially Equivalent

Intersect Systems, Inc.

FDA 510(k) clearance K913225 for URINE/CSF MICROPROTEIN REAGENT, Substantially Equivalent on 1991-10-11. Applicant: Intersect Systems, Inc.. Device class: 2.

Clearance details

Applicant: Intersect Systems, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1991-07-19
Decision date: 1991-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longview, WA, US

Download summary PDF View on FDA.gov ↗

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