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510(k) K100715

AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 by Aalto Scientific, Ltd. — Product Code JJX

K100715 is an FDA 510(k) premarket notification submitted by Aalto Scientific, Ltd. for the device "AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5". The FDA issued a decision of Substantially Equivalent on December 23, 2010. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Aalto Scientific, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2010
Date Received
March 12, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Aalto Scientific, Ltd.

  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K143571 — Audit MicroControls Linearity LQ Cystatin-C (January 23, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K143026 — Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity (November 21, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)
  • K130762 — AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET (April 29, 2013)
  • K130764 — AUDIT MICROCV VITAMIN D LINEARITY SET (April 26, 2013)
  • K130157 — AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET (March 19, 2013)
  • K112742 — AUDIT MICROLQ SPINAL FLUID CONTROL (June 15, 2012)

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (January 12, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (April 21, 2016)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (July 17, 2015)

FDA data resources