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510(k) K792407

ELVI-AMINOLEVULINIC ACID by Volu Sol Medical Industries — Product Code DIJ

K792407 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "ELVI-AMINOLEVULINIC ACID". The FDA issued a decision of Substantially Equivalent on January 16, 1980. The device falls under product code DIJ (Lead, Delta Amino Levulinic Acid), a Class II device regulated under 21 CFR 862.3550. Volu Sol Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1980
Date Received
November 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lead, Delta Amino Levulinic Acid
Device Class
Class II
Regulation Number
862.3550
Review Panel
TX
Submission Type

Other clearances by Volu Sol Medical Industries

  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)
  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (August 5, 1982)
  • K822035 — VOLU-SOL GILLS EA (August 3, 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)
  • K812906 — ELVI BICLOT 816 (July 22, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)

Other clearances for product code DIJ

  • K030826 — PRECISET DAT AMPHETAMINE (April 3, 2003)

FDA data resources