Home / 510(k) Clearances / K800324

510(k) K800324

VOLU-SOL HARRIS HEMATOXYLIN by Volu Sol Medical Industries — Product Code HYK

K800324 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "VOLU-SOL HARRIS HEMATOXYLIN". The FDA issued a decision of Substantially Equivalent on February 22, 1980. The device falls under product code HYK (Hematoxylin Harris'S), 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 22, 1980
Date Received
February 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hematoxylin Harris'S
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Volu Sol Medical Industries

  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (August 5, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K822036 — VOLU-SOL DECALCIFER (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 HYK

  • K873107 — INSTANT HEMATOXYLIN (August 21, 1987)
  • K872498 — HARRIS HEMATOXYLIN (July 9, 1987)
  • K843425 — HARRIS HEMATOXYLIN, MERCURY FREE, ACID (October 2, 1984)
  • K823328 — HARRIS HEMATOXYLIN (December 28, 1982)
  • K810733 — HARRIS HEMATOXYLIN (April 14, 1981)
  • K781585 — HEMATOXYLIN STAIN HARRIS (October 10, 1978)

FDA data resources