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510(k) K871694

HYPERFORMANCE CONTROLS (HP-CONTROLS) by Rapid Diagnostic Laboratories, Inc. — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1987
Date Received
April 28, 1987
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.

  • K903909 — BLIND CONTROLS FOR DRUGS OF ABUSE TESTING (October 26, 1990)
  • K890030 — NEW LOW LEVEL DRUG MIXTURE CONTROL (January 23, 1989)
  • K875216 — HIGH PERFORMANCE CALIBRATORS (June 22, 1988)
  • K863117 — HIGH PERFORMANCE CANNABINOID CONTROLS (September 25, 1986)
  • K850139 — COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER (April 10, 1985)

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