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510(k) K800322

VOLU-SOL EA-50 STAIN by Volu Sol Medical Industries — Product Code HZJ

K800322 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "VOLU-SOL EA-50 STAIN". The FDA issued a decision of Substantially Equivalent on February 26, 1980. The device falls under product code HZJ (Stain, Papanicolau), 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
February 26, 1980
Date Received
February 12, 1980
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)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K812906 — ELVI BICLOT 816 (July 22, 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)
  • K842739 — PAP STAIN, EA-36 (September 11, 1984)
  • K842735 — PAP STAIN EA-65 (September 11, 1984)
  • K842736 — PAP STAIN, OG-6 (August 17, 1984)
  • K842738 — PAP STAIN EA-50 (August 17, 1984)
  • K840054 — PAPANICOLAOU STAIN SYS HT40 (February 17, 1984)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K820027 — MODIFIED EA 50 (February 4, 1982)
  • K812086 — EA 65 (August 13, 1981)
  • K812087 — EA 50 (August 13, 1981)

FDA data resources