Home / 510(k) Clearances / K923034

510(k) K923034

MILES URINE CALCIUM METHOD by Heraeus Kulzer, Inc. — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1992
Date Received
June 19, 1992
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 Heraeus Kulzer, Inc.

  • K130647 — XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X (May 17, 2013)
  • K123278 — IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF (December 7, 2012)
  • K120914 — FLEXITIME FAST & SCAN LIGHT FLOW (July 25, 2012)
  • K113574 — FLEXITIME MONOPHASE PRO SCAN (July 13, 2012)
  • K112501 — VENUS PEARL PLT REFILL A1 (December 14, 2011)
  • K111832 — PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID (September 29, 2011)
  • K110037 — PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID (April 29, 2011)
  • K102770 — FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCA (December 21, 2010)
  • K101617 — FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CAR (September 7, 2010)
  • K093575 — GLUMA DESENSITIZER POWER GEL (March 5, 2010)

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)