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510(k) K790943

TRISEDTA-BORATE ELECTROPHORESIS FILM AGA by Corning Medical & Scientific — Product Code GHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1979
Date Received
May 18, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Carboxyhemoglobin
Device Class
Class II
Regulation Number
864.7425
Review Panel
HE
Submission Type

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  • K850806 — CORNING BLOOD COLLECTION CAPILLARY TUBES (March 25, 1985)
  • K850617 — CORNING 780 FLUOROMETER/DENSITOMETER (March 12, 1985)

Other clearances for product code GHS

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  • K770209 — ECOLYZER CARBOXIMETER (March 7, 1977)