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510(k) K770400

REAGENT, AMYLASE LIPASE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KHM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1977
Date Received
March 2, 1977
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

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  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (June 28, 2000)
  • K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (April 25, 2000)
  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (October 1, 1999)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code KHM

  • K831295 — AMYLASE REAGENT #88129 (June 30, 1983)
  • K812699 — AMYLASE (October 6, 1981)
  • K812447 — AMYLASE REAGENT KIT (September 9, 1981)
  • K801096 — PERKIN ELMER MODEL 91 AMYLASE REAGENT (June 9, 1980)
  • K790797 — AMYLASE REAGENT SET (July 17, 1979)