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510(k) K812699

AMYLASE by Pointe Scientific, Inc., — Product Code KHM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1981
Date Received
September 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometric, Amylase
Device Class
Class II
Regulation Number
862.1070
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 KHM

  • K831295 — AMYLASE REAGENT #88129 (June 30, 1983)
  • K812447 — AMYLASE REAGENT KIT (September 9, 1981)
  • K801096 — PERKIN ELMER MODEL 91 AMYLASE REAGENT (June 9, 1980)
  • K790797 — AMYLASE REAGENT SET (July 17, 1979)
  • K770400 — REAGENT, AMYLASE LIPASE (April 26, 1977)