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510(k) K973102

LIDOCAINE EIA ASSAY by Diagnostic Reagents, Inc. — Product Code KLR

K973102 is an FDA 510(k) premarket notification submitted by Diagnostic Reagents, Inc. for the device "LIDOCAINE EIA ASSAY". The FDA issued a decision of Substantially Equivalent on September 12, 1997. The device falls under product code KLR (Enzyme Immunoassay, Lidocaine), a Class II device regulated under 21 CFR 862.3555. Diagnostic Reagents, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1997
Date Received
August 19, 1997
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 Diagnostic Reagents, Inc.

  • K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (November 18, 1998)
  • K983812 — NAPA EIA ASSAY (November 16, 1998)
  • K983323 — DIGOXIN IMMUNOASSAY (November 12, 1998)
  • K983280 — VANCOMYCIN EIA ASSAY (November 6, 1998)
  • K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS (November 5, 1998)
  • K972835 — 50NG/ML COCAINE METABOLITE CALIBRATOR (August 28, 1997)
  • K972526 — METHADONE EIA ASSAY (August 4, 1997)
  • K964212 — QUINIDINE ENZYME IMMUNOASSAY (December 18, 1996)
  • K963835 — DIGOXIN ENZYME IMMUNOASSAY (December 10, 1996)
  • K962463 — PROCAINAMIDE ENZYME IMMUNOASSAY (August 14, 1996)

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)
  • 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)
  • K833381 — VALPROIC ACID ANALYTICAL TEST PACK (December 27, 1983)
  • K833379 — LIDOCAINE ANALYTICAL TEST PACK ACA (December 27, 1983)
  • K833623 — MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY (December 8, 1983)
  • K832799 — MODIFICA- OF EMIT CAD LIDOCAINE ASSAY (October 14, 1983)

FDA data resources