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510(k) K822038

VOLU-SOL ORANGE G-6(GILLS-MOD by Volu Sol Medical Industries — Product Code HZH

K822038 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "VOLU-SOL ORANGE G-6(GILLS-MOD". The FDA issued a decision of Substantially Equivalent on August 3, 1982. The device falls under product code HZH (Orange G), 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
August 3, 1982
Date Received
July 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orange G
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Volu Sol Medical Industries

  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (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)
  • K822036 — VOLU-SOL DECALCIFER (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 HZH

  • K842924 — ORANGE G, 1% (September 7, 1984)
  • K811825 — ORANGE G-6 (July 10, 1981)
  • K800323 — VOLU-SOL ORANGE G-6 STAIN (February 22, 1980)

FDA data resources