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510(k) K811825

ORANGE G-6 by Surgipath — Product Code HZH

K811825 is an FDA 510(k) premarket notification submitted by Surgipath for the device "ORANGE G-6". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code HZH (Orange G), 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
Orange G
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)
  • 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)
  • K810733 — HARRIS HEMATOXYLIN (April 14, 1981)

Other clearances for product code HZH

  • K842924 — ORANGE G, 1% (September 7, 1984)
  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K800323 — VOLU-SOL ORANGE G-6 STAIN (February 22, 1980)

FDA data resources