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510(k) K843895

TOTAL CALCIUM REAGENT SET by Livonia Diagnostics, Inc. — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1984
Date Received
October 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresolphthalein Complexone, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Livonia Diagnostics, Inc.

  • K852161 — SERUM IRON/VIBC REAGENT SET (June 10, 1985)
  • K844283 — SGPT REAGENT SET (November 27, 1984)
  • K844322 — SGOT REAGENT SET (November 27, 1984)
  • K844237 — ALKALINE PHOSPHATASE REAGENT SET (November 20, 1984)
  • K844156 — UREA NITROGEN REAGENT SET (November 13, 1984)
  • K844182 — INORGANIC PHOSPHORUS REAGENT SET (November 9, 1984)
  • K843894 — HDL PRECIPATATING REAGENT SET (November 2, 1984)
  • K844075 — URIC ACID REAGENT SET (October 30, 1984)
  • K843893 — MAGNESIUM REAGENT SET (October 30, 1984)
  • K844024 — CREATININE REAGENT SET (October 30, 1984)

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  • K053401 — SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (March 24, 2006)
  • K050077 — SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS (February 15, 2005)
  • K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT (June 25, 2004)
  • K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR (March 13, 2003)
  • K013652 — WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 (December 21, 2001)
  • K000375 — RANDOX CALCIUM (April 5, 2000)
  • K991111 — BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110 (May 25, 1999)