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510(k) K860660

AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS by Amresco, Inc. — Product Code CHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1986
Date Received
February 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coulometric Method, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
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 CHS

  • K926320 — REFLAB SYSTEM PACK LIQUID CO2 REAGENT (February 3, 1993)
  • K911838 — ROCHE REAGENT FOR C02 (July 19, 1991)
  • K841080 — TECHNICON RA-1000 SYS CO2 (May 2, 1984)
  • K811257 — CORNING 965 CARBON DIOXIDE ANALYZER (May 27, 1981)
  • K802376 — KODAK EKTA-CHEM CLINICAL CHEM. SLIDES (October 23, 1980)