Home / 510(k) Clearances / K123127

510(k) K123127

VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 by Maine Standards Co. — Product Code JJX

K123127 is an FDA 510(k) premarket notification submitted by Maine Standards Co. for the device "VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406". The FDA issued a decision of Substantially Equivalent on June 14, 2013. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Maine Standards Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2013
Date Received
October 4, 2012
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 Maine Standards Co.

  • K113524 — VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT (January 27, 2012)
  • K103271 — MSC LIPID CONTROL (January 25, 2011)
  • K091225 — VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET (June 25, 2009)
  • K090475 — VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 (April 16, 2009)
  • K083891 — VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 (March 23, 2009)
  • K082067 — MSC LIPID CONTROL (August 22, 2008)
  • K072246 — VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 (September 14, 2007)
  • K062501 — VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 (September 29, 2006)
  • K053247 — VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET (January 13, 2006)
  • K050504 — VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS (March 25, 2005)

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)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161526 — LIAISON CMV 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