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510(k) K812447

AMYLASE REAGENT KIT by Bioscientific — Product Code KHM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1981
Date Received
August 28, 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

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Other clearances for product code KHM

  • K831295 — AMYLASE REAGENT #88129 (June 30, 1983)
  • K812699 — AMYLASE (October 6, 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)