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510(k) K142978

Audit MicroControls Linearity LQ Special Diabetes by Aalto Scientific, Ltd. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2014
Date Received
October 15, 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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  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
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  • K130762 — AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET (April 29, 2013)
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  • K112742 — AUDIT MICROLQ SPINAL FLUID CONTROL (June 15, 2012)
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Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • 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)
  • K133676 — ABX PENTRA MICRO ALB CONTROL L/H (July 11, 2014)