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510(k) K810758

GILL'S HEMATOXYLIN #1 by Surgipath — Product Code HYJ

K810758 is an FDA 510(k) premarket notification submitted by Surgipath for the device "GILL'S HEMATOXYLIN #1". The FDA issued a decision of Substantially Equivalent on April 14, 1981. The device falls under product code HYJ (Hematoxylin), 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 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hematoxylin
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)
  • K810760 — GILL'S HEMATOXYLIN #3 (April 14, 1981)
  • K810759 — GILL'S HEMATOXYLIN #2 (April 14, 1981)
  • K810733 — HARRIS HEMATOXYLIN (April 14, 1981)

Other clearances for product code HYJ

  • K872500 — ANATECH HEMATOXYLIN-EXTRA STRENGTH (July 9, 1987)
  • K872499 — ANATECH HEMATOXYLIN-NORMAL STRENGTH (July 9, 1987)
  • K842740 — DELAFIELD HEMATOXYLIN STAIN (August 17, 1984)
  • K842741 — GILL HEMATOXYLIN STAIN (August 15, 1984)
  • K831090 — HEMATOXYLIN GILL FORMULATION IX#56016 (June 8, 1983)
  • K822352 — HEMATOXYLIN STAIN SOLUTION (August 16, 1982)
  • K821533 — HEMATOXYLIN I (June 10, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)
  • K821541 — HEMATOXYLIN III (June 10, 1982)
  • K821320 — HEMATOXYLIN STAIN (June 2, 1982)

FDA data resources