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510(k) K801265

WHITE BLOOD CELL COUNT CONTROL LEVELS by Bioscientific — Product Code JPK

K801265 is an FDA 510(k) premarket notification submitted by Bioscientific for the device "WHITE BLOOD CELL COUNT CONTROL LEVELS". The FDA issued a decision of Substantially Equivalent on July 14, 1980. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Bioscientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1980
Date Received
May 28, 1980
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 Bioscientific

  • K812447 — AMYLASE REAGENT KIT (September 9, 1981)
  • K811251 — CITRATE BUFFER (May 21, 1981)
  • K801267 — RED BLOOD CELL COUNT & HEMATOCRIT CNTL (July 14, 1980)
  • K801268 — HEMOGLOBIN CONTROL LEVELS (July 14, 1980)
  • K791658 — WRIGHT STAIN PACK (October 17, 1979)
  • K791007 — STAT DIFF STAIN (August 3, 1979)
  • K790415 — HCP-7 (April 4, 1979)
  • K781734 — SODIUM CHLORIDE, 0.85% (October 24, 1978)
  • K781587 — HEMATOLOGY STAIN PACK (October 10, 1978)
  • K781584 — GRAM STAIN KIT (October 10, 1978)

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