Home / 510(k) Clearances / K822035

510(k) K822035

VOLU-SOL GILLS EA by Volu Sol Medical Industries — Product Code HZJ

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
Stain, Papanicolau
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)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (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)
  • K821533 — HEMATOXYLIN I (June 10, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)

Other clearances for product code HZJ

  • K843427 — GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (October 2, 1984)
  • K842735 — PAP STAIN EA-65 (September 11, 1984)
  • K842739 — PAP STAIN, EA-36 (September 11, 1984)
  • K842738 — PAP STAIN EA-50 (August 17, 1984)
  • K842736 — PAP STAIN, OG-6 (August 17, 1984)
  • K840054 — PAPANICOLAOU STAIN SYS HT40 (February 17, 1984)
  • K820027 — MODIFIED EA 50 (February 4, 1982)
  • K812087 — EA 50 (August 13, 1981)
  • K812086 — EA 65 (August 13, 1981)
  • K800325 — VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 (February 26, 1980)