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510(k) K792403

ELVI URIC ACID-COLORIMETRIC METHOD by Volu Sol Medical Industries — Product Code CDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1979
Date Received
November 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Phosphotungstate Reduction
Device Class
Class I
Regulation Number
862.1775
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)
  • 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 CDH

  • K850933 — URIC ACID (June 25, 1985)
  • K841067 — URIC ACID REAGENT SET (May 1, 1984)
  • K821213 — URIC ACID REAGENT SET (July 13, 1982)
  • K813076 — PHOSPHOTUNGSTATE REDUCTION, URIC ACID (November 16, 1981)
  • K810088 — URIC ACID (TPTZ) COLORINMETRIC (January 28, 1981)
  • K800672 — SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC (May 28, 1980)
  • K800190 — STANBIO DIRECT URIC ACID TEST SET #0770 (February 13, 1980)
  • K792412 — ELVI URIC ACID (December 7, 1979)
  • K790019 — SERUM, URIC ACID DETERMINATION (February 26, 1979)
  • K772082 — ENZAC URIC ACID 100-TEST KIT (November 28, 1977)