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510(k) K091052

PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM by Abaxis, Inc. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2010
Date Received
April 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

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  • K120662 — PICCOLO HDL-CAPILLARY TEST SYSTEM (April 24, 2012)
  • K091910 — PICCOLO MAGNESIUM TEST SYSTEM (October 1, 2009)
  • K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (July 8, 2005)
  • K040115 — PICCOLO MAGNESIUM TEST SYSTEM (January 30, 2004)
  • K023642 — PICCOLO TOTAL CHOLESTEROL TEST SYSTEM (January 24, 2003)
  • K023639 — PICCOLO TRIGLYCERIDES TEST SYSTEM (January 24, 2003)

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  • K171498 — MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (January 12, 2018)
  • K161982 — C-Reactive Protein Kit for use on SPAPLUS (April 5, 2017)
  • K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (August 17, 2012)
  • K083444 — C-REACTIVE PROTEIN (LATEX) (March 18, 2009)
  • K083412 — PATHFAST HSCRP (March 9, 2009)