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510(k) K101434

AUDIT MICROCV PROCALCITONIN LINEARITY by Aalto Scientific, Ltd. — Product Code MJX

K101434 is an FDA 510(k) premarket notification submitted by Aalto Scientific, Ltd. for the device "AUDIT MICROCV PROCALCITONIN LINEARITY". The FDA issued a decision of Substantially Equivalent on July 22, 2010. The device falls under product code MJX (Kit, Serological, Positive Control), 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
July 22, 2010
Date Received
May 21, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Serological, Positive Control
Device Class
Class I
Regulation Number
862.1660
Review Panel
MI
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 MJX

  • K030067 — VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (January 17, 2003)
  • K974262 — SYSCOS IDC - G, IDC, BSC, IDC - G (December 24, 1997)
  • K972986 — ACCURUN 140 RUBELLA IGG POSITIVE CONTROL (October 8, 1997)
  • K970100 — TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SER (March 10, 1997)
  • K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION (March 7, 1994)
  • K925703 — OPUS SEROLOGY CONTROLS (April 8, 1993)

FDA data resources