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510(k) K812945

LIQUILYME BUN REAGENT by Amresco, Inc. — Product Code LFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1981
Date Received
October 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conductivity Rate, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Amresco, Inc.

  • K905618 — GGT REAGENT (February 26, 1991)
  • K904468 — DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 (January 17, 1991)
  • K905684 — ALKALINE PHOSPHATASE (December 28, 1990)
  • K905544 — MAGNESIUM REAGENT (December 27, 1990)
  • K905284 — HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 (December 11, 1990)
  • K904004 — AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 (December 11, 1990)
  • K905096 — GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 (November 28, 1990)
  • K904381 — DIAZO COLORIMENTRY DIRECT BILIRUBIN (October 12, 1990)
  • K903775 — CREATINE PHOSPHOKINASE (October 4, 1990)
  • K903829 — AST REAGENT (September 25, 1990)

Other clearances for product code LFP

  • K990039 — GAMBRO DQM 200 (January 27, 2000)
  • K992847 — HICHEM BUN REAGENT (October 14, 1999)
  • K963537 — SIGMA DIAGNOSTICS BUN REAGENT (October 24, 1996)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K873132 — BUN REAGENT KIT (October 23, 1987)