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510(k) DEN040008

CEDIA SIROLIMUS ASSAY by Microgenics Corp. — Product Code NRP

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
July 28, 2004
Date Received
June 17, 2004
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sirolimus Test System
Device Class
Class II
Regulation Number
862.3840
Review Panel
TX
Submission Type

Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.

Other clearances by Microgenics Corp.

  • K122766 — THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY (August 20, 2013)
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  • K123271 — ABBOTT PHENOBARBITAL ASSAY (April 26, 2013)
  • K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO (June 29, 2011)
  • K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (April 8, 2011)
  • K101742 — THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY (April 8, 2011)
  • K101753 — THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY (April 8, 2011)
  • K101744 — THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY (April 8, 2011)
  • K101746 — THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (April 8, 2011)
  • K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (April 8, 2011)

Other clearances for product code NRP

  • K083487 — EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND (March 30, 2009)
  • K081857 — DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS (October 30, 2008)
  • K070822 — ARCHITECT SIROLIMUS ASSAY (September 28, 2007)
  • K042411 — ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY (April 7, 2005)