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510(k) K792554

ELVI MUCAPROTEINS by Volu Sol Medical Industries — Product Code JQN

K792554 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "ELVI MUCAPROTEINS". The FDA issued a decision of Substantially Equivalent on January 16, 1980. The device falls under product code JQN (Colorimetric, Mucopolysaccharides), a Class I device regulated under 21 CFR 862.1505. 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
Colorimetric, Mucopolysaccharides
Device Class
Class I
Regulation Number
862.1505
Review Panel
CH
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)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 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)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K812906 — ELVI BICLOT 816 (July 22, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)

Other clearances for product code JQN

  • K863070 — FAST MUCOPROTEINS (September 11, 1986)

FDA data resources