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510(k) K011878

EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL by Syva Co. — Product Code DKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2001
Date Received
June 15, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Salicylate
Device Class
Class II
Regulation Number
862.3830
Review Panel
TX
Submission Type

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Other clearances for product code DKJ

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  • K014173 — SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR (February 15, 2002)
  • K981872 — SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 (June 29, 1998)
  • K980032 — SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 (March 2, 1998)
  • K964715 — PARAMAX SALICYLATE REAGENT (April 25, 1997)
  • K961131 — SALICYLATE ASSAY (April 29, 1996)
  • K951290 — AXSYM SALICYLATE (August 8, 1995)
  • K946000 — ABUSCREEN ONLINE(R) CALIBRATORS (January 25, 1995)