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510(k) K903909

BLIND CONTROLS FOR DRUGS OF ABUSE TESTING by Rapid Diagnostic Laboratories, Inc. — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
August 22, 1990
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 Rapid Diagnostic Laboratories, Inc.

  • K890030 — NEW LOW LEVEL DRUG MIXTURE CONTROL (January 23, 1989)
  • K875216 — HIGH PERFORMANCE CALIBRATORS (June 22, 1988)
  • K871694 — HYPERFORMANCE CONTROLS (HP-CONTROLS) (July 7, 1987)
  • K863117 — HIGH PERFORMANCE CANNABINOID CONTROLS (September 25, 1986)
  • K850139 — COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER (April 10, 1985)

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