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510(k) K791007

STAT DIFF STAIN by Bioscientific — Product Code KQC

K791007 is an FDA 510(k) premarket notification submitted by Bioscientific for the device "STAT DIFF STAIN". The FDA issued a decision of Substantially Equivalent on August 3, 1979. The device falls under product code KQC (Stains, Hematology), a Class I device regulated under 21 CFR 864.1850. Bioscientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1979
Date Received
May 31, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Hematology
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
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)
  • K801265 — WHITE BLOOD CELL COUNT CONTROL LEVELS (July 14, 1980)
  • K791658 — WRIGHT STAIN PACK (October 17, 1979)
  • K790415 — HCP-7 (April 4, 1979)
  • K781734 — SODIUM CHLORIDE, 0.85% (October 24, 1978)
  • K781583 — PAPANICOLAOU STAIN :EA-50: (October 10, 1978)
  • K781584 — GRAM STAIN KIT (October 10, 1978)

Other clearances for product code KQC

  • K882873 — FIELDTEX HEMATOXYLIN (July 28, 1988)
  • K852843 — GENERAL DIAGNOSTICS COAG-A-MATE XC (August 13, 1985)
  • K843619 — RETIC-SET (October 30, 1984)
  • K841848 — RETIC-SET (May 31, 1984)
  • K792550 — PONCEAU S STAIN SET (January 16, 1980)
  • K792496 — VOLU-SOL NMB RETICULOCYTE STAIN (December 31, 1979)
  • K760485 — HEMASTAIN FIXATIVE (August 30, 1976)
  • K760487 — HEMASTAIN PHOSPHATE BUFFER (August 30, 1976)

FDA data resources