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510(k) K881116

EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 by Diagnostic Systems — Product Code KLR

K881116 is an FDA 510(k) premarket notification submitted by Diagnostic Systems for the device "EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641". The FDA issued a decision of Substantially Equivalent on June 20, 1988. The device falls under product code KLR (Enzyme Immunoassay, Lidocaine), a Class II device regulated under 21 CFR 862.3555. Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1988
Date Received
March 15, 1988
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 Systems

  • K905146 — OLYMPUS URINE PH (February 4, 1991)
  • K893691 — EMDS CREATINE KINASE ITEM NIMBER 65411 (August 31, 1989)
  • K893692 — EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 (August 21, 1989)
  • K893966 — HDL PRECIPITATING REAGENT (July 25, 1989)
  • K884993 — VISUAL BLOOD GLUCOSE TEST SYSTEM (December 29, 1988)
  • K880787 — EASY-TEST LACTIC ACID (LA) (March 15, 1988)
  • K862403 — EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 (July 11, 1986)
  • K854784 — ABSORBANCE (ABS) TEST PAK (December 19, 1985)
  • K853699 — EASY ANALYZER & EASY-TEST REAGENT (September 25, 1985)
  • K853533 — ABSORBANCE TEST SOLUTION (September 16, 1985)

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)
  • 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)
  • K832799 — MODIFICA- OF EMIT CAD LIDOCAINE ASSAY (October 14, 1983)

FDA data resources