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510(k) K910527

EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE by Syva Co. — Product Code DJD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1991
Date Received
February 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Primidone
Device Class
Class II
Regulation Number
862.3680
Review Panel
TX
Submission Type

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  • 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 DJD

  • K973582 — ACE PRIMIDONE REAGENT, AED CALIBRATORS (November 12, 1997)
  • K840939 — EMIT QST PRIMIDONE ASSAY (April 24, 1984)
  • K832798 — MODIFICA-OF EMIT AED PRIMIDONE ASSAY (October 14, 1983)
  • K820138 — PRIMIDONE REAGENT TEST KIT (January 28, 1982)
  • K813597 — TDX PRIMIDONE (January 22, 1982)
  • K802654 — AMES TDA PRIMIDONE TEST (November 12, 1980)
  • K781957 — ANALYTICAL TEST PACK, PRIMIDONE (January 10, 1979)