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510(k) K970664

GLUCOSE REAGENT by Derma Media Lab., Inc. — Product Code CFR

K970664 is an FDA 510(k) premarket notification submitted by Derma Media Lab., Inc. for the device "GLUCOSE REAGENT". The FDA issued a decision of Substantially Equivalent on August 1, 1997. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Derma Media Lab., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1997
Date Received
February 21, 1997
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 Derma Media Lab., Inc.

  • K971309 — UREA (August 1, 1997)
  • K971072 — CHOLESTEROL REAGENT (June 20, 1997)
  • K971005 — TRIGLYCERIDES (April 21, 1997)
  • K970867 — URIC ACID REAGENT (April 21, 1997)
  • K964915 — MAGNESIUM (March 26, 1997)
  • K964913 — IRON REAGENT (February 20, 1997)
  • K965134 — ALT/SGPT (February 18, 1997)
  • K964914 — ALKALINE PHOSPHATASE (February 4, 1997)
  • K965126 — AST/SGOT (January 17, 1997)
  • K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE (January 10, 1997)

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