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510(k) K002199

MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET by Pointe Scientific, Inc., — Product Code CFR

K002199 is an FDA 510(k) premarket notification submitted by Pointe Scientific, Inc., for the device "MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET". The FDA issued a decision of Substantially Equivalent on November 20, 2000. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Pointe Scientific, Inc., has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2000
Date Received
July 20, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Pointe Scientific, Inc.,

  • K070757 — MICROPROTEIN REAGENT SET (December 4, 2007)
  • K062118 — POINTE 360 (July 13, 2007)
  • K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT (April 30, 2007)
  • K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR (April 13, 2007)
  • K070504 — AMMONIA/ALCOHOL CONTROL SET (April 11, 2007)
  • K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (March 28, 2007)
  • K051646 — ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH (October 7, 2005)
  • K040391 — TOTAL BILIRUBIN REAGENT SET (June 2, 2004)
  • K031539 — HEMOGLOBIN A1C REAGENT SET (August 6, 2003)
  • K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS (April 28, 2003)

Other clearances for product code CFR

  • K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (February 12, 2026)
  • K252357 — Glucose2 (October 24, 2025)
  • K220134 — cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ON (September 16, 2022)
  • K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated s (August 16, 2019)
  • K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM (October 19, 2017)
  • K153644 — ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITe (September 7, 2016)
  • K151487 — Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose He (January 14, 2016)
  • K131189 — UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) (April 17, 2014)
  • K123018 — ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELEC (April 23, 2013)
  • K120681 — ADVIA CHEMISTRY GLUH_3 REAGENTS (May 15, 2012)

FDA data resources