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510(k) K040352

NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) by Bioresource Technology, Inc. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2004
Date Received
February 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Bioresource Technology, Inc.

  • K060850 — NOD CHEMISTRY CONTROL (May 30, 2006)
  • K023032 — LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL (October 8, 2002)
  • K944728 — BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS (March 23, 1995)

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  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)