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510(k) K822036

VOLU-SOL DECALCIFER by Volu Sol Medical Industries — Product Code KDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1982
Date Received
July 12, 1982
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 Volu Sol Medical Industries

  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)
  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (August 5, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K812906 — ELVI BICLOT 816 (July 22, 1982)
  • K821533 — HEMATOXYLIN I (June 10, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)

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)
  • K821443 — FORMICAL (June 2, 1982)
  • K811801 — CAL-RITE (July 28, 1981)
  • K810836 — DECALCIFIER II (April 23, 1981)