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510(k) K993980

SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL by Syva Co. — Product Code DML

K993980 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL". The FDA issued a decision of Substantially Equivalent on February 1, 2000. The device falls under product code DML (Nad-Nadh, Specific Reagent For Alcohol Enzyme Method), a Class II device regulated under 21 CFR 862.3040. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2000
Date Received
November 24, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Device Class
Class II
Regulation Number
862.3040
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)
  • 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)
  • K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (January 27, 2000)

Other clearances for product code DML

  • K013538 — ETHANOL (December 14, 2001)
  • K963197 — ON.SITE ALCOHOL (September 19, 1996)
  • K953765 — AXSYM REA ETHANOL (September 27, 1995)
  • K952839 — BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY (August 24, 1995)
  • K923337 — ON*SITE ALCOHOL (January 12, 1993)
  • K914777 — SIGMA PROCEDURE NO. 333-UV (December 27, 1991)
  • K874382 — RAICHEM(TM) ALCOHOL REAGENT (January 11, 1988)
  • K872180 — KINETIC 610 ETHANOL (July 7, 1987)
  • K863419 — EMDS(TM) ALCOHOL TESTPACKS, #67691/95 (September 29, 1986)
  • K840769 — PARAMAX ALCOHOL REAGENT (April 13, 1984)

FDA data resources