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510(k) K813244

UV URIC ACID DETERMINATION by Biorent Diagnostic, Inc. — Product Code CDO

K813244 is an FDA 510(k) premarket notification submitted by Biorent Diagnostic, Inc. for the device "UV URIC ACID DETERMINATION". The FDA issued a decision of Substantially Equivalent on December 8, 1981. The device falls under product code CDO (Acid, Uric, Uricase (U.V.)), a Class I device regulated under 21 CFR 862.1775. Biorent Diagnostic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1981
Date Received
November 18, 1981
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 Biorent Diagnostic, Inc.

  • K832747 — ALBUMIN REAGENT SET (October 14, 1983)
  • K823060 — HEMOGLOBIN REAGENT (November 22, 1982)
  • K823211 — CK-UV REAGENT (November 22, 1982)
  • K822493 — OPTIMIZED UV-GOT REAGENT SET (September 21, 1982)
  • K822494 — OPTIMIZED UV-GPT REAGENT SET (September 21, 1982)
  • K822492 — OPTIMIZED UV-LDH REAGENT SET (September 17, 1982)
  • K820768 — COLORIMETRIC LDH REAGENT SET (April 14, 1982)
  • K820632 — COLORIMETRIC URIC ACID REAGENT SET (March 25, 1982)
  • K813555 — GLUCOSE ENZYME-COLOR REAGENT SET (January 18, 1982)
  • K811760 — CHOLESTEROL DETERMINATION (July 10, 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