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510(k) K853050

CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ by Simmler, Inc. — Product Code CIC

K853050 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ". The FDA issued a decision of Substantially Equivalent on August 2, 1985. The device falls under product code CIC (Cresolphthalein Complexone, Calcium), a Class II device regulated under 21 CFR 862.1145. Simmler, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1985
Date Received
July 19, 1985
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 Simmler, Inc.

  • K895745 — SICKLE CELL SOLUBILITY TEST KIT (November 29, 1989)
  • K874903 — MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (February 11, 1988)
  • K874595 — MULTICHEM (R) MAGNESIUM REAGENT (January 21, 1988)
  • K874820 — MULTICHEM HDL PRECIPITATING REAGENT #S0914 (January 7, 1988)
  • K874812 — MULTICHEM CHLORIDE REAGENT S0933 (December 18, 1987)
  • K874311 — MULTICHEM (R) TOTAL BILIRUBIN (November 25, 1987)
  • K874049 — MULTICHEM ALBUMIN REAGENT S0902 (October 29, 1987)
  • K874038 — MULTICHEM INORGANIC PHOSPHOROUS S0923 (October 28, 1987)
  • K873725 — MULTICHEM CREATININE REAGENT S0917 (October 20, 1987)
  • K873761 — MULTICHEM ALKALINE PHOSPHATASE (S0903) (October 7, 1987)

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