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510(k) K792495

VOLU-SOL URINARY SEDIMENT STAIN by Volu Sol Medical Industries — Product Code ICF

K792495 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "VOLU-SOL URINARY SEDIMENT STAIN". The FDA issued a decision of Substantially Equivalent on December 18, 1979. The device falls under product code ICF (Crystal Violet For Histology), a Class I device regulated under 21 CFR 864.1850. Volu Sol Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1979
Date Received
December 4, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crystal Violet For Histology
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Volu Sol Medical Industries

  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (August 5, 1982)
  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K822036 — VOLU-SOL DECALCIFER (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)

Other clearances for product code ICF

  • K864531 — TISSUE GRAM STAIN (December 22, 1986)
  • K842537 — VON WILLEBRAND FACTOR ANTIGEN SCREEN (October 1, 1984)
  • K842730 — GENTIAN VIOLET (August 3, 1984)
  • K821503 — IRIS URINE STAIN (June 3, 1982)

FDA data resources