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510(k) K781585

HEMATOXYLIN STAIN HARRIS by Bioscientific — Product Code HYK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1978
Date Received
September 18, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hematoxylin Harris'S
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Bioscientific

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  • K801265 — WHITE BLOOD CELL COUNT CONTROL LEVELS (July 14, 1980)
  • K801268 — HEMOGLOBIN CONTROL LEVELS (July 14, 1980)
  • K801267 — RED BLOOD CELL COUNT & HEMATOCRIT CNTL (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)
  • K781582 — PAPANICOLAOU STAIN EA-36 (October 10, 1978)

Other clearances for product code HYK

  • K873107 — INSTANT HEMATOXYLIN (August 21, 1987)
  • K872498 — HARRIS HEMATOXYLIN (July 9, 1987)
  • K843425 — HARRIS HEMATOXYLIN, MERCURY FREE, ACID (October 2, 1984)
  • K823328 — HARRIS HEMATOXYLIN (December 28, 1982)
  • K810733 — HARRIS HEMATOXYLIN (April 14, 1981)
  • K800324 — VOLU-SOL HARRIS HEMATOXYLIN (February 22, 1980)