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510(k) K811826

EOSIN Y by Surgipath — Product Code HYB

K811826 is an FDA 510(k) premarket notification submitted by Surgipath for the device "EOSIN Y". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code HYB (Eosin Y), 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
July 10, 1981
Date Received
June 29, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Eosin Y
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)
  • K812087 — EA 50 (August 13, 1981)
  • K812086 — EA 65 (August 13, 1981)
  • K811825 — ORANGE G-6 (July 10, 1981)
  • K810836 — DECALCIFIER II (April 23, 1981)
  • K810758 — GILL'S HEMATOXYLIN #1 (April 14, 1981)
  • K810759 — GILL'S HEMATOXYLIN #2 (April 14, 1981)
  • K810733 — HARRIS HEMATOXYLIN (April 14, 1981)
  • K810760 — GILL'S HEMATOXYLIN #3 (April 14, 1981)

Other clearances for product code HYB

  • K893663 — INSTANT EOSIN-AQUEOUS (June 13, 1989)
  • K880596 — EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE (March 31, 1988)
  • K880240 — INSTANT EOSIN-ALCOHOLIC (March 3, 1988)
  • K843426 — EOSIN Y 1% ALCOHOLIC (September 27, 1984)
  • K822982 — MIDAS 100 HEMACOLOR STAIN #66030 (October 27, 1982)
  • K821574 — EOSIN Y SOLUTIN, AGUEOUS (June 10, 1982)
  • K821573 — EOSIN Y SOLUTION ALCHOLIC (June 9, 1982)
  • K811797 — EOSIN-Y (July 28, 1981)
  • K800942 — VOLU-SOL EOSIN Y STAIN (May 8, 1980)

FDA data resources