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510(k) K875216

HIGH PERFORMANCE CALIBRATORS by Rapid Diagnostic Laboratories, Inc. — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1988
Date Received
December 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
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)
  • 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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