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510(k) K121122

DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL by Biochemical Diagnostic, Inc. — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2012
Date Received
April 13, 2012
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 Biochemical Diagnostic, Inc.

  • K050328 — PREGNANCY-SKREEN (March 29, 2005)
  • K925586 — DETECTABUSE(TM) (December 28, 1992)
  • K904181 — ANTI-GBM ANTIBODIES QUANTITATIVE KIT (September 10, 1991)
  • K841831 — CANNU-SKREEN-PRELIMINARY (July 6, 1984)

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