Home / 510(k) Clearances / K810733

510(k) K810733

HARRIS HEMATOXYLIN by Surgipath — Product Code HYK

K810733 is an FDA 510(k) premarket notification submitted by Surgipath for the device "HARRIS HEMATOXYLIN". The FDA issued a decision of Substantially Equivalent on April 14, 1981. The device falls under product code HYK (Hematoxylin Harris'S), a Class I device regulated under 21 CFR 864.1850. Surgipath has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1981
Date Received
March 18, 1981
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 Surgipath

  • K820027 — MODIFIED EA 50 (February 4, 1982)
  • K812940 — 10% NEUTRAL BUFFERED FORMALIN CONCENT (December 10, 1981)
  • K812086 — EA 65 (August 13, 1981)
  • K812087 — EA 50 (August 13, 1981)
  • K811825 — ORANGE G-6 (July 10, 1981)
  • K811826 — EOSIN Y (July 10, 1981)
  • K810836 — DECALCIFIER II (April 23, 1981)
  • K810758 — GILL'S HEMATOXYLIN #1 (April 14, 1981)
  • K810760 — GILL'S HEMATOXYLIN #3 (April 14, 1981)
  • K810759 — GILL'S HEMATOXYLIN #2 (April 14, 1981)

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)
  • K800324 — VOLU-SOL HARRIS HEMATOXYLIN (February 22, 1980)
  • K781585 — HEMATOXYLIN STAIN HARRIS (October 10, 1978)

FDA data resources