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510(k) K810836

DECALCIFIER II by Surgipath — Product Code KDX

K810836 is an FDA 510(k) premarket notification submitted by Surgipath for the device "DECALCIFIER II". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code KDX (Solution, Decalcifier, Acid Containing), a Class I device regulated under 21 CFR 864.4010. Surgipath has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1981
Date Received
March 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Decalcifier, Acid Containing
Device Class
Class I
Regulation Number
864.4010
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)
  • 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 KDX

  • K872625 — DECALCIFYING SOLUTION (August 6, 1987)
  • K850636 — SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E (March 20, 1985)
  • K842726 — DECALCIFIER SOLUTION (August 3, 1984)
  • K841488 — DECALCIFIER I (May 2, 1984)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 1982)
  • K821443 — FORMICAL (June 2, 1982)
  • K811801 — CAL-RITE (July 28, 1981)

FDA data resources