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510(k) K822129

VOLU-SOL BOVINS FIXATIVE by Volu Sol Medical Industries — Product Code IGN

K822129 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "VOLU-SOL BOVINS FIXATIVE". The FDA issued a decision of Substantially Equivalent on August 5, 1982. The device falls under product code IGN (Fluid, Bouin'S), a Class I device regulated under 21 CFR 864.4010. Volu Sol Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1982
Date Received
July 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluid, Bouin'S
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Volu Sol Medical Industries

  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)
  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (August 5, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (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 IGN

  • K833515 — BOUINS SOLUTION (November 14, 1983)

FDA data resources