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510(k) K860751

VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA by Bio/Data Corp. — Product Code JPK

K860751 is an FDA 510(k) premarket notification submitted by Bio/Data Corp. for the device "VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA". The FDA issued a decision of Substantially Equivalent on March 18, 1986. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Bio/Data Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1986
Date Received
February 28, 1986
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 Bio/Data Corp.

  • K001891 — MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C (July 12, 2000)
  • K943153 — MICROSAMPLE COAGULATION ANALYZER (March 24, 1995)
  • K893650 — PLATELET AGGREGATION PROFILER MODEL PAP-4C (June 23, 1989)
  • K881150 — KINETIC FIBRINOGEN ASSAY (March 28, 1988)
  • K873382 — PLATELET EXTRACT REAGENT (November 20, 1987)
  • K860342 — MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP (March 4, 1986)
  • K854546 — MICROSAMPLE COAGULATION ANALYSER MODEL 110P (January 7, 1986)
  • K853897 — CITREX H (October 10, 1985)
  • K853246 — CALCIUM CHLORIDE (August 13, 1985)
  • K852484 — PLASTINEX (August 12, 1985)

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