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510(k) K012878

THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 by Thermo Dma, Inc. — Product Code JIS

K012878 is an FDA 510(k) premarket notification submitted by Thermo Dma, Inc. for the device "THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609". The FDA issued a decision of Substantially Equivalent on October 16, 2001. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Thermo Dma, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2001
Date Received
August 28, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Thermo Dma, Inc.

  • K022108 — THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 (July 25, 2002)
  • K012518 — TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 (October 9, 2001)
  • K012525 — THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 (October 4, 2001)

Other clearances for product code JIS

  • K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (August 14, 2012)
  • K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (May 31, 2006)
  • K060266 — DIMENSION IRON CALIBRATOR (March 9, 2006)
  • K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (December 23, 2005)
  • K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (November 7, 2003)
  • K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (October 21, 2003)
  • K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (August 13, 2003)
  • K030964 — CALIBRATION PLASMA LMW HEPARIN (June 6, 2003)
  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)
  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)

FDA data resources