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510(k) K831354

EMIT QST LIDOCAINE ASSAY by Syva Co. — Product Code KLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1983
Date Received
April 26, 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

Other clearances by Syva Co.

  • K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA (August 13, 2001)
  • K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (August 3, 2001)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K993983 — SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL (January 27, 2000)
  • K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (January 27, 2000)

Other clearances for product code KLR

  • K090282 — QMS LIDOCAINE (May 29, 2009)
  • K033809 — DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRA (February 20, 2004)
  • 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)
  • K833623 — MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY (December 8, 1983)