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510(k) K801143

VOLU-SOL URINARY DICHROME STAIN by Volu Sol Medical Industries — Product Code IDA

K801143 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "VOLU-SOL URINARY DICHROME STAIN". The FDA issued a decision of Substantially Equivalent on May 30, 1980. The device falls under product code IDA (Alcian Blue), 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
May 30, 1980
Date Received
May 18, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alcian Blue
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)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (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)
  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K812906 — ELVI BICLOT 816 (July 22, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)

Other clearances for product code IDA

  • K832496 — BIO SURE STAIN (September 12, 1983)

FDA data resources