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510(k) K822036

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

K822036 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "VOLU-SOL DECALCIFER". The FDA issued a decision of Substantially Equivalent on August 3, 1982. The device falls under product code KDX (Solution, Decalcifier, Acid Containing), a Class I device regulated under 21 CFR 864.4010. Volu Sol Medical Industries has at least 10 other 510(k) clearances on record.

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

  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (August 5, 1982)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822126 — VOLU-SOL CARNOY FLUID (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)
  • K821540 — HEMATOXYLIN II (June 10, 1982)
  • K821533 — HEMATOXYLIN I (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)

FDA data resources