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510(k) K850933

URIC ACID by Dilab, Inc. — Product Code CDH

K850933 is an FDA 510(k) premarket notification submitted by Dilab, Inc. for the device "URIC ACID". The FDA issued a decision of Substantially Equivalent on June 25, 1985. The device falls under product code CDH (Acid, Uric, Phosphotungstate Reduction), a Class I device regulated under 21 CFR 862.1775. Dilab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
March 7, 1985
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 Dilab, Inc.

  • K862530 — RAPID AS LATEX (April 21, 1987)
  • K850931 — ALBUMIN (June 26, 1985)
  • K850938 — CHOLESTEROL (June 25, 1985)
  • K850934 — PHOSPHORUS (June 25, 1985)
  • K850932 — CREATININE (June 25, 1985)
  • K850936 — TOTAL PROTEINS (June 25, 1985)
  • K850937 — UREA (June 10, 1985)
  • K850930 — GLUCOSE (June 10, 1985)
  • K850935 — CHLORIDE (June 10, 1985)
  • K850929 — CALCIUM (June 10, 1985)

Other clearances for product code CDH

  • 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)
  • K792403 — ELVI URIC ACID-COLORIMETRIC METHOD (December 7, 1979)
  • 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)

FDA data resources