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510(k) K863117

HIGH PERFORMANCE CANNABINOID CONTROLS by Rapid Diagnostic Laboratories, Inc. — Product Code LAS

K863117 is an FDA 510(k) premarket notification submitted by Rapid Diagnostic Laboratories, Inc. for the device "HIGH PERFORMANCE CANNABINOID CONTROLS". The FDA issued a decision of Substantially Equivalent on September 25, 1986. The device falls under product code LAS (Drug Specific Control Materials), a Class I device regulated under 21 CFR 862.3280. Rapid Diagnostic Laboratories, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1986
Date Received
August 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Specific 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)
  • K871694 — HYPERFORMANCE CONTROLS (HP-CONTROLS) (July 7, 1987)
  • K850139 — COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER (April 10, 1985)

Other clearances for product code LAS

  • K080459 — CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS (November 17, 2009)
  • K072257 — MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (January 30, 2008)
  • K062942 — QUANTIMETRIX NICOSURE COTININE URINE CONTROL (October 30, 2006)
  • K051074 — MAS IMMUNOSUPPRESSANT CONTROLS (June 6, 2005)
  • K040411 — DRI OXYCODONE ASSAY (May 27, 2004)
  • K032842 — MICROGENICS CYCLOSPORINE CONTROL KIT (October 17, 2003)
  • K030616 — CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (March 31, 2003)
  • K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (July 14, 1999)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • K971210 — SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (April 17, 1997)

FDA data resources