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510(k) K904990

EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS by Syva Co. — Product Code LBZ

K904990 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS". The FDA issued a decision of Substantially Equivalent on February 4, 1991. The device falls under product code LBZ (Enzyme Immunoassay, Quinidine), a Class II device regulated under 21 CFR 862.3320. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1991
Date Received
November 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Quinidine
Device Class
Class II
Regulation Number
862.3320
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)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K993988 — SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL (January 27, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)

Other clearances for product code LBZ

  • K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (December 23, 2005)
  • K032332 — ROCHE ONLINE TDM QUINIDINE (January 12, 2004)
  • K011605 — EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 (June 12, 2001)
  • K964116 — QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (December 24, 1996)
  • K964212 — QUINIDINE ENZYME IMMUNOASSAY (December 18, 1996)
  • K955568 — INNOFLUOR QUINIDINE ASSAY SYSTEM (April 4, 1996)
  • K941440 — COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS (July 6, 1994)
  • K922913 — EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS (August 24, 1992)
  • K900705 — MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR (April 12, 1990)
  • K892208 — INNOFLUOR(TM) QUINIDINE REAGENT SET (June 9, 1989)

FDA data resources