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510(k) K792555

ELVI NON-ESTERIFIED FATTY ACIDS by Volu Sol Medical Industries — Product Code JLH

K792555 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "ELVI NON-ESTERIFIED FATTY ACIDS". The FDA issued a decision of Substantially Equivalent on January 16, 1980. The device falls under product code JLH (Titrimetric, Fatty Acids), a Class I device regulated under 21 CFR 862.1290. 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
December 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Titrimetric, Fatty Acids
Device Class
Class I
Regulation Number
862.1290
Review Panel
CH
Submission Type

Other clearances by Volu Sol Medical Industries

  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (August 5, 1982)
  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 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)
  • K812906 — ELVI BICLOT 816 (July 22, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)

FDA data resources