Home / 510(k) Clearances / K140916

510(k) K140916

LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK by Bio-Rad Laboratories — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2014
Date Received
April 10, 2014
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

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  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)