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510(k) K833623

MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY by Syva Co. — Product Code KLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1983
Date Received
October 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Lidocaine
Device Class
Class II
Regulation Number
862.3555
Review Panel
TX
Submission Type

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Other clearances for product code KLR

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  • K032334 — ROCHE ONLINE TDM LIDOCAINE (January 12, 2004)
  • K973102 — LIDOCAINE EIA ASSAY (September 12, 1997)
  • K881116 — EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (June 20, 1988)
  • K853010 — COBAS REAGENT FOR LIDOCAINE & CALIBRATORS (August 7, 1985)
  • K843184 — STRATUS LIDOCAINE FLUOROMETRIC ENZYME (September 26, 1984)
  • K833379 — LIDOCAINE ANALYTICAL TEST PACK ACA (December 27, 1983)
  • K833381 — VALPROIC ACID ANALYTICAL TEST PACK (December 27, 1983)
  • K832799 — MODIFICA- OF EMIT CAD LIDOCAINE ASSAY (October 14, 1983)