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510(k) K964715

PARAMAX SALICYLATE REAGENT by Dade Intl., Inc. — Product Code DKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1997
Date Received
November 25, 1996
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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  • K972287 — DADE TRU-LIQUID BILIRUBIN CONTROL (July 7, 1997)
  • K964660 — PARAMAX CHOLESTEROL REAGENT (June 4, 1997)
  • K970676 — DRIED GRAM-NEGATIVE MIC/COMBO PANELS (May 2, 1997)
  • K970330 — DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE (April 14, 1997)

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  • K980032 — SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 (March 2, 1998)
  • K961131 — SALICYLATE ASSAY (April 29, 1996)
  • K951290 — AXSYM SALICYLATE (August 8, 1995)
  • K946000 — ABUSCREEN ONLINE(R) CALIBRATORS (January 25, 1995)