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510(k) K080459

CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS by Chromsystems Instruments & Chemicals GmbH — Product Code LAS

K080459 is an FDA 510(k) premarket notification submitted by Chromsystems Instruments & Chemicals GmbH for the device "CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS". The FDA issued a decision of Substantially Equivalent on November 17, 2009. The device falls under product code LAS (Drug Specific Control Materials), a Class I device regulated under 21 CFR 862.3280.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2009
Date Received
February 20, 2008
Clearance Type
Abbreviated
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

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  • 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)
  • K946119 — ROCHE-TDM ONLEIN(TM) CONTROLS (February 7, 1995)

FDA data resources