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510(k) K926320

REFLAB SYSTEM PACK LIQUID CO2 REAGENT by Medical Analysis Systems, Inc. — Product Code CHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1993
Date Received
December 15, 1992
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

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  • K031364 — MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 (May 30, 2003)
  • K030942 — MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL (April 28, 2003)

Other clearances for product code CHS

  • K911838 — ROCHE REAGENT FOR C02 (July 19, 1991)
  • K860660 — AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS (March 14, 1986)
  • 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)