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510(k) K922835

CALCIUM (AZ III) REAGENT by King Diagnostics, Inc. — Product Code CJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1992
Date Received
June 12, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo Dye, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by King Diagnostics, Inc.

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  • K931773 — HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) (August 16, 1993)
  • K931326 — KING DIAGNOSTICS CK REAGENT (June 15, 1993)
  • K923129 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT (November 2, 1992)
  • K922969 — KING DIAGNOSTICS UREA NITROGEN REAGENT (October 13, 1992)
  • K922921 — KING DIAGNOSTICS CHLORIDE REAGENT (October 5, 1992)
  • K923927 — KING DIAGNOSTICS MAGNESIUM REAGENT (September 30, 1992)
  • K923091 — KING DIAGNOSTICS GAMMA GT REAGENT (September 9, 1992)
  • K923128 — KING DIAGNOSTICS CHOLESTEROL REAGENT (September 9, 1992)

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  • K072356 — S-TEST CA (June 24, 2008)
  • K073355 — CALCIUM, SCAL, NORTROL, ABTROL (February 28, 2008)
  • K072443 — VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (September 24, 2007)