MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL— 510(k) K012243

Name: FDA 510(k) clearance K012243
Creator: U.S. Food and Drug Administration
Published: 2001-08-20

Substantially Equivalent

Hematronix, Inc.

FDA 510(k) clearance K012243 for MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL, Substantially Equivalent on 2001-08-20. Applicant: Hematronix, Inc.. Device class: 1.

Clearance details

Applicant: Hematronix, Inc.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2001-07-17
Decision date: 2001-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Benicia, CA, US

Download summary PDF View on FDA.gov ↗

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