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510(k) K992151

REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE by Consolidated Technologies, Inc. — Product Code LAS

K992151 is an FDA 510(k) premarket notification submitted by Consolidated Technologies, Inc. for the device "REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE". The FDA issued a decision of Substantially Equivalent on July 14, 1999. The device falls under product code LAS (Drug Specific Control Materials), a Class I device regulated under 21 CFR 862.3280. Consolidated Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1999
Date Received
June 24, 1999
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 Consolidated Technologies, Inc.

  • K000116 — QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 (February 15, 2000)
  • K992576 — URINE CHEMISTRY CONTROL, LEVEL 1 (September 3, 1999)
  • K992578 — URINE CHEMISTRY CONTROL, LEVEL 2 (September 3, 1999)
  • K981339 — QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 (April 21, 1998)
  • K974699 — REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE (January 22, 1998)
  • K973469 — QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UN (September 25, 1997)
  • K972146 — QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS (July 8, 1997)
  • K972080 — QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONT (June 18, 1997)
  • K961815 — QUALITROL ANA CONTROL SERUM SET (September 27, 1996)
  • K961550 — QUALITROL MONO CONTROL SERUM SET (September 24, 1996)

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)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • K971210 — SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (April 17, 1997)
  • K946119 — ROCHE-TDM ONLEIN(TM) CONTROLS (February 7, 1995)

FDA data resources