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510(k) K023032

LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL by Bioresource Technology, Inc. — Product Code GFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2002
Date Received
September 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Standards And Controls, Hemoglobin, Normal And Abnormal
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Bioresource Technology, Inc.

  • K060850 — NOD CHEMISTRY CONTROL (May 30, 2006)
  • K040352 — NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) (April 2, 2004)
  • K944728 — BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS (March 23, 1995)