HEMOCHEK URINE COLLECTION KIT— 510(k) K991800

Name: FDA 510(k) clearance K991800
Creator: U.S. Food and Drug Administration
Published: 1999-09-24

Substantially Equivalent

Osborn Group, Inc.

FDA 510(k) clearance K991800 for HEMOCHEK URINE COLLECTION KIT, Substantially Equivalent on 1999-09-24. Applicant: Osborn Group, Inc.. Device class: 1.

Clearance details

Applicant: Osborn Group, Inc.
Product code: Code JIQ
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1999-05-26
Decision date: 1999-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Olathe, KS, US

Download summary PDF View on FDA.gov ↗

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