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510(k) K050077

SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS by Arkray, Inc. — Product Code CIC

K050077 is an FDA 510(k) premarket notification submitted by Arkray, Inc. for the device "SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS". The FDA issued a decision of Substantially Equivalent on February 15, 2005. The device falls under product code CIC (Cresolphthalein Complexone, Calcium), a Class II device regulated under 21 CFR 862.1145. Arkray, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2005
Date Received
January 12, 2005
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 Arkray, Inc.

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  • K193514 — AUTION MAX AX-4060 Urinalysis System (April 13, 2023)
  • K221175 — Multi-Lancet Device 2, ReliOn Premier Lancing Device (October 17, 2022)
  • K200788 — Assure Titanium Blood Glucose Monitoring System (May 23, 2022)
  • K160062 — AUTION ELEVEN Semi-Automated Urinalysis System (October 7, 2016)
  • K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET (February 1, 2013)
  • K093098 — AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (December 23, 2009)
  • K053401 — SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (March 24, 2006)
  • K051648 — SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (January 31, 2006)
  • K051432 — SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS (June 17, 2005)

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)
  • 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)
  • K971907 — CALCIUM REAGENT (June 24, 1997)

FDA data resources