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510(k) K033879

VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 by Maine Standards Co. — Product Code DKB

K033879 is an FDA 510(k) premarket notification submitted by Maine Standards Co. for the device "VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126". The FDA issued a decision of Substantially Equivalent on February 27, 2004. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Maine Standards Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2004
Date Received
December 15, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Maine Standards Co.

  • K123127 — VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 (June 14, 2013)
  • 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)

Other clearances for product code DKB

  • K141928 — COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR (November 25, 2014)
  • K133710 — LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS (February 21, 2014)
  • K120936 — ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT (December 13, 2012)
  • K092266 — RANDOX METHAMPHETAMINE ASSAY (May 9, 2011)
  • K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (April 8, 2011)
  • K090939 — ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLIN (June 18, 2009)
  • K090900 — ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 (June 1, 2009)
  • K062162 — DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) (September 14, 2006)
  • K062121 — DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) (August 25, 2006)
  • K060645 — PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRAT (May 30, 2006)

FDA data resources