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510(k) K941433

HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH by Hichem Diagnostics — Product Code JJX

K941433 is an FDA 510(k) premarket notification submitted by Hichem Diagnostics for the device "HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH". The FDA issued a decision of Substantially Equivalent on August 2, 1994. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Hichem Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1994
Date Received
March 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
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)
  • K953863 — HICHEM ISE STANDARDS KIT 70011 (September 6, 1995)
  • K953862 — HICHEM ISEKCI SOLUTION KIT 70010 (September 6, 1995)
  • K953860 — HICHEM ISE DILUENT KIT 70008 (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)
  • K925551 — HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 (April 20, 1993)

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (January 12, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (April 21, 2016)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (July 17, 2015)

FDA data resources