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510(k) K972725

ALCOHOL REAGENT SET by Pointe Scientific, Inc., — Product Code DIC

K972725 is an FDA 510(k) premarket notification submitted by Pointe Scientific, Inc., for the device "ALCOHOL REAGENT SET". The FDA issued a decision of Substantially Equivalent on September 25, 1997. The device falls under product code DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method), a Class II device regulated under 21 CFR 862.3040. Pointe Scientific, Inc., has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1997
Date Received
July 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
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 DIC

  • K250609 — Sober Self-Test (September 15, 2025)
  • K181553 — Immunalysis Ethyl Alcohol Enzyme Assay (October 31, 2018)
  • K121247 — ALCO-SCREEN (March 22, 2013)
  • K121256 — ALCO-SCREEN 02 (September 12, 2012)
  • K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL (November 15, 2011)
  • K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST (October 4, 2011)
  • K092273 — RANDOX ETHANOL ASSAY (November 1, 2010)
  • K093879 — MISSION SALIVA ALCOHOL TEST STRIP (August 6, 2010)
  • K071811 — ETOH FLEX REAGENT CARTRIDGE (DF22) (August 24, 2007)
  • K070853 — DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 (June 13, 2007)

FDA data resources