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510(k) K142964

VALIDATE Anemia Calibration Verification/ Linearity Test Kit by Maine Standards Company, LLC — Product Code JJY

K142964 is an FDA 510(k) premarket notification submitted by Maine Standards Company, LLC for the device "VALIDATE Anemia Calibration Verification/ Linearity Test Kit". The FDA issued a decision of Substantially Equivalent on April 30, 2015. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Maine Standards Company, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2015
Date Received
October 14, 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

Other clearances by Maine Standards Company, LLC

  • K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (June 21, 2017)
  • K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit (March 16, 2017)
  • K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (January 5, 2017)
  • K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (June 3, 2016)
  • K133550 — VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT (February 5, 2014)
  • K110880 — VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT (July 5, 2011)

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)
  • 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)
  • K133676 — ABX PENTRA MICRO ALB CONTROL L/H (July 11, 2014)

FDA data resources