URINE SCREENING DEVICE— 510(k) K972676

Name: FDA 510(k) clearance K972676
Creator: U.S. Food and Drug Administration
Published: 1998-02-23

Substantially Equivalent

Combact Diagnostic Systems , Ltd.

FDA 510(k) clearance K972676 for URINE SCREENING DEVICE, Substantially Equivalent on 1998-02-23. Applicant: Combact Diagnostic Systems , Ltd.. Device class: 1.

Clearance details

Applicant: Combact Diagnostic Systems , Ltd.
Product code: Code JXA
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1997-07-16
Decision date: 1998-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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