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510(k) K792407

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

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

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  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 1982)
  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K812906 — ELVI BICLOT 816 (July 22, 1982)
  • K821533 — HEMATOXYLIN I (June 10, 1982)

Other clearances for product code DIJ

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