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510(k) K812110

GILCHEM CALCIUM REAGENT by Gilford Diagnostics — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1981
Date Received
July 27, 1981
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 Gilford Diagnostics

  • K832094 — BILIRUBIN CALIBRATORS & CONTROL (August 11, 1983)
  • K831844 — DIRECT BILIRUBIN REAGENT (July 18, 1983)
  • K831843 — GILCHEM TOTAL BILIRUBIN REAGENT (July 18, 1983)
  • K823709 — TRIGLYCERIDE REAGENT (UV) (January 7, 1983)
  • K822739 — AHBD (October 18, 1982)
  • K822334 — BILIRUBIN CALIBRATORS (September 2, 1982)
  • K822289 — CO2/CI STANDARDS (August 24, 1982)
  • K822149 — GILCHEM Y-GT REAGENT (August 12, 1982)
  • K821719 — AMMONIA REAGENT (June 24, 1982)
  • K820975 — GILCHEM ACID PHOSPHATASE REAGENT (April 26, 1982)

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  • 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)