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510(k) K961131

SALICYLATE ASSAY by Diagnostic Reagents, Inc. — Product Code DKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1996
Date Received
March 21, 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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  • K972526 — METHADONE EIA ASSAY (August 4, 1997)
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  • K980032 — SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 (March 2, 1998)
  • K964715 — PARAMAX SALICYLATE REAGENT (April 25, 1997)
  • K951290 — AXSYM SALICYLATE (August 8, 1995)
  • K946000 — ABUSCREEN ONLINE(R) CALIBRATORS (January 25, 1995)