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510(k) K792377

CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL by Environmental Chemical Specialties — Product Code DHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
November 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Carcinoembryonic Antigen
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances by Environmental Chemical Specialties

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  • K811810 — URIC ACID TEST (July 15, 1981)
  • K811811 — TDM ANTI-CONVULSANT CONTROL LEVELS I-II (July 10, 1981)
  • K811809 — ANTI-ARRHYTHMIC CONTROL LEVELS I & II (July 10, 1981)
  • K803089 — GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) (January 2, 1981)
  • K801854 — SPINAL FLUID CONTROL(HUMAN) (September 16, 1980)
  • K801061 — TOTAL PROTEIN TEST (July 21, 1980)
  • K792375 — ELEVATED LIPID CONTROL (December 6, 1979)
  • K792376 — QUANTITATIVE CONTROL URINE II (HUMAN) (December 6, 1979)
  • K792374 — QUANTITATIVE CONTROL URINE I (HUMAN) (December 6, 1979)

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  • K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (March 18, 2009)
  • K080194 — VIDAS CEA (S) ASSAY (October 9, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K041322 — VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS (June 17, 2004)
  • K031270 — ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS (May 6, 2003)
  • K023893 — ST AIA-PACK CEA ENZYME IMMUNOASSAY (December 18, 2002)
  • K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 21, 2001)