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510(k) K941965

EZ-RANGE by Hematronix, Inc. — Product Code JPK

K941965 is an FDA 510(k) premarket notification submitted by Hematronix, Inc. for the device "EZ-RANGE". The FDA issued a decision of Substantially Equivalent on April 25, 1995. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Hematronix, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1995
Date Received
April 22, 1994
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

Other clearances by Hematronix, Inc.

  • K012243 — MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL (August 20, 2001)
  • K993496 — RETIC-QUINOX (November 30, 1999)
  • K972710 — QUANTIFY(901) (August 15, 1997)
  • K960471 — TRI-COUNT 20 (March 20, 1996)
  • K960005 — TRI-COURT 20-T (March 19, 1996)
  • K935343 — CENTRIFIQ BLOOD CONTROL (January 27, 1994)
  • K904461 — METER TRAX (October 26, 1990)
  • K902389 — TRI-COUNT 16 (August 22, 1990)

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