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510(k) K091303

LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV by Bio-Rad Laboratories — Product Code JPK

K091303 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV". The FDA issued a decision of Substantially Equivalent on August 2, 2010. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2010
Date Received
May 4, 2009
Clearance Type
Traditional
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

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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)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K141964 — XN CHECK (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