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510(k) K992395

URINE DRUG SCREENING CONTROL by Seracare Technology — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1999
Date Received
July 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Seracare Technology

  • K993631 — QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 (December 9, 1999)
  • K992939 — QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 (December 9, 1999)
  • K993715 — QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (November 16, 1999)
  • K992770 — QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 (November 12, 1999)

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