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510(k) K030546

CRP (II) CALIBRATORS by Denka Seiken Co., Ltd. — Product Code JIS

K030546 is an FDA 510(k) premarket notification submitted by Denka Seiken Co., Ltd. for the device "CRP (II) CALIBRATORS". The FDA issued a decision of Substantially Equivalent on June 2, 2003. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Denka Seiken Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2003
Date Received
February 20, 2003
Clearance Type
Traditional
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 Denka Seiken Co., Ltd.

  • K161679 — s LDL-EX SEIKEN (August 18, 2017)
  • K060359 — ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 (April 14, 2006)
  • K043264 — LDL-EX SEIKEN ASSAY KIT (January 26, 2005)
  • K041090 — HDL-EX SEIKEN ASSAY KIT (October 29, 2004)
  • K030545 — CRP-LATEX (II)X2 SEIKEN ASSAY KIT (June 2, 2003)

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)
  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)
  • K022682 — RANDOX C-REACTIVE PROTEIN CALIBRATOR (November 5, 2002)

FDA data resources