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510(k) K953863

HICHEM ISE STANDARDS KIT 70011 by Hichem Diagnostics — Product Code JIX

K953863 is an FDA 510(k) premarket notification submitted by Hichem Diagnostics for the device "HICHEM ISE STANDARDS KIT 70011". The FDA issued a decision of Substantially Equivalent on September 6, 1995. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Hichem Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1995
Date Received
August 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Hichem Diagnostics

  • K981794 — HICHEM CALCIUM REAGENT KIT (July 29, 1998)
  • K963383 — HICHEM ALP/AMP REAGENT KIT (September 23, 1996)
  • K953860 — HICHEM ISE DILUENT KIT 70008 (September 6, 1995)
  • K953862 — HICHEM ISEKCI SOLUTION KIT 70010 (September 6, 1995)
  • K953861 — HICHEM ISE INTDERNAL REFERENCE KIT 70009 (September 6, 1995)
  • K951751 — HICHEM AST REAGENT KIT (August 2, 1995)
  • K946192 — HICHEM Y-GT REAGENT KIT (May 2, 1995)
  • K946022 — HICHEM LDH/L REAGENT KIT (February 23, 1995)
  • K941433 — HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH (August 2, 1994)
  • K925551 — HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 (April 20, 1993)

Other clearances for product code JIX

  • K161140 — VITROS Chemistry Products Calibrator Kit 3 (May 20, 2016)
  • K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator (December 18, 2015)
  • K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech C (July 8, 2015)
  • K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium F (June 15, 2015)
  • K141388 — SYSTEM CALIBRATER (July 11, 2014)
  • K133330 — C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PR (November 26, 2013)
  • K130765 — ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH C (April 4, 2013)
  • K123321 — DIMENSION CHEMISTRY III CALIBRATORY (February 15, 2013)
  • K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR (January 14, 2013)
  • K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS (October 12, 2012)

FDA data resources