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510(k) K091433

R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL by R&D Systems, Inc. — Product Code JPK

K091433 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL". The FDA issued a decision of Substantially Equivalent on October 28, 2009. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2009
Date Received
May 13, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixture, Hematology Quality Control
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by R&D Systems, Inc.

  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)
  • K100050 — R & D SYSTEMS XERET HEMATOLOGY CONTROL (January 29, 2010)
  • K073178 — HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 (December 27, 2007)
  • K072846 — CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 (November 26, 2007)
  • K072268 — HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S (November 20, 2007)
  • K072096 — CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 (August 20, 2007)
  • K070334 — R&D SICKLE QC CONTROL (March 29, 2007)
  • K061511 — R&D CBC-3D + CRP HEMATOLOGY CONTROL (July 10, 2006)

Other clearances for product code JPK

  • K160586 — XN-L CHECK (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141964 — XN CHECK (December 5, 2014)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K120742 — XN CHECK (October 19, 2012)
  • K120744 — XN CHECK BF (October 19, 2012)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)

FDA data resources