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510(k) K790834

UV URIC ACID DETERMINATION by The Dow Chemical Co. — Product Code CDO

K790834 is an FDA 510(k) premarket notification submitted by The Dow Chemical Co. for the device "UV URIC ACID DETERMINATION". The FDA issued a decision of Substantially Equivalent on June 28, 1979. The device falls under product code CDO (Acid, Uric, Uricase (U.V.)), a Class I device regulated under 21 CFR 862.1775. The Dow Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1979
Date Received
April 30, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Uricase (U.V.)
Device Class
Class I
Regulation Number
862.1775
Review Panel
CH
Submission Type

Other clearances by The Dow Chemical Co.

  • K823474 — ENZYMATIC GLUCOSE DETERMINATION (December 30, 1982)
  • K822154 — UREA NITROGEN (ENZYMATIC) DETERMINATION (August 5, 1982)
  • K821536 — DOWFLOW ALT-UV DETERMINATION (June 14, 1982)
  • K821315 — DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM (May 24, 1982)
  • K820675 — BILIRUBIN(TOTAL) DETERMINATION CTMS (April 1, 1982)
  • K820714 — DOW BILIRUBIN(DIRECT) DETERMINATION (April 1, 1982)
  • K812777 — DIRECT IRON REAGENT SET (October 19, 1981)
  • K811806 — QUICK-CHEM COLORIMETER (July 15, 1981)
  • K810861 — CREATINE KINASE MB ISOENZYME IMMUNO UV (April 14, 1981)
  • K810727 — AST-UV (PLP-ACTIVATED) DETERMINATION (March 31, 1981)

Other clearances for product code CDO

  • K033278 — RANDOX URIC ACID (February 27, 2004)
  • K992798 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, (September 28, 1999)
  • K982251 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT (August 18, 1998)
  • K981766 — URIC ACID (June 19, 1998)
  • K981189 — URIC ACID (May 7, 1998)
  • K971485 — URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (May 27, 1997)
  • K955752 — OLYMPUS URIC ACID REAGENT (January 31, 1996)
  • K932162 — URIC ACID TEST ITEM NUMBER 65422 (September 27, 1993)
  • K923765 — SYSTEMATE URICACID TEST, TECHNICON RA 1000 (September 22, 1992)
  • K903335 — SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 (August 17, 1990)

FDA data resources