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510(k) K843895

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

K843895 is an FDA 510(k) premarket notification submitted by Livonia Diagnostics, Inc. for the device "TOTAL CALCIUM REAGENT SET". The FDA issued a decision of Substantially Equivalent on October 30, 1984. The device falls under product code CIC (Cresolphthalein Complexone, Calcium), a Class II device regulated under 21 CFR 862.1145. Livonia Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K844322 — SGOT REAGENT SET (November 27, 1984)
  • K844283 — SGPT 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)
  • K844024 — CREATININE REAGENT SET (October 30, 1984)
  • K844075 — URIC ACID REAGENT SET (October 30, 1984)
  • K843893 — MAGNESIUM REAGENT SET (October 30, 1984)

Other clearances for product code CIC

  • K130870 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) (May 2, 2013)
  • K083339 — DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) (March 9, 2009)
  • K070249 — ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONT (April 26, 2007)
  • 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)

FDA data resources