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510(k) K822128

VOLU-SOL SINGLE DIFFERENTIAL STAIN by Volu Sol Medical Industries — Product Code ICN

K822128 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "VOLU-SOL SINGLE DIFFERENTIAL STAIN". The FDA issued a decision of Substantially Equivalent on August 5, 1982. The device falls under product code ICN (Biebrich Scarlet), 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 5, 1982
Date Received
July 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biebrich Scarlet
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)
  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS 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)
  • K821533 — HEMATOXYLIN I (June 10, 1982)

Other clearances for product code ICN

  • K833273 — MASSON TRICHROME STAIN HT15 (October 31, 1983)

FDA data resources