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510(k) K033910

OLYMPUS URINE CALIBRATOR by Cliniqa Corporation — Product Code JIX

K033910 is an FDA 510(k) premarket notification submitted by Cliniqa Corporation for the device "OLYMPUS URINE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on January 30, 2004. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Cliniqa Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2004
Date Received
December 17, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Cliniqa Corporation

  • K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (May 31, 2013)
  • K121237 — BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA (May 18, 2012)
  • K083554 — CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 (April 21, 2009)
  • K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 (January 16, 2009)
  • K082107 — CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 (September 17, 2008)
  • K080973 — CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC M (June 2, 2008)
  • K070741 — CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & (May 4, 2007)
  • K062916 — CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 (October 23, 2006)
  • K061182 — CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS (May 25, 2006)
  • K060322 — CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMIS (March 21, 2006)

Other clearances for product code JIX

  • K161140 — VITROS Chemistry Products Calibrator Kit 3 (May 20, 2016)
  • K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator (December 18, 2015)
  • K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech C (July 8, 2015)
  • K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium F (June 15, 2015)
  • K141388 — SYSTEM CALIBRATER (July 11, 2014)
  • K133330 — C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PR (November 26, 2013)
  • K130765 — ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH C (April 4, 2013)
  • K123321 — DIMENSION CHEMISTRY III CALIBRATORY (February 15, 2013)
  • K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR (January 14, 2013)
  • K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS (October 12, 2012)

FDA data resources