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510(k) K800190

STANBIO DIRECT URIC ACID TEST SET #0770 by Stanbio Laboratory — Product Code CDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1980
Date Received
January 29, 1980
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

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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)
  • K792412 — ELVI URIC ACID (December 7, 1979)
  • K792403 — ELVI URIC ACID-COLORIMETRIC METHOD (December 7, 1979)
  • K790019 — SERUM, URIC ACID DETERMINATION (February 26, 1979)
  • K772082 — ENZAC URIC ACID 100-TEST KIT (November 28, 1977)