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510(k) K820632

COLORIMETRIC URIC ACID REAGENT SET by Biorent Diagnostic, Inc. — Product Code KNK

K820632 is an FDA 510(k) premarket notification submitted by Biorent Diagnostic, Inc. for the device "COLORIMETRIC URIC ACID REAGENT SET". The FDA issued a decision of Substantially Equivalent on March 25, 1982. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), 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
March 25, 1982
Date Received
March 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Uricase (Colorimetric)
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)
  • K813555 — GLUCOSE ENZYME-COLOR REAGENT SET (January 18, 1982)
  • K813244 — UV URIC ACID DETERMINATION (December 8, 1981)
  • K811760 — CHOLESTEROL DETERMINATION (July 10, 1981)

Other clearances for product code KNK

  • K102568 — URIC ACID MODEL 3P39 (May 6, 2011)
  • K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (April 6, 2007)
  • K040467 — VITALAB URIC ACID REAGENT (March 8, 2004)
  • K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (July 15, 2003)
  • K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (March 18, 2003)
  • K023550 — WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (December 9, 2002)
  • K012038 — JAS URIC ACID LIQUID REAGENT (August 21, 2001)
  • K010421 — WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X5 (April 13, 2001)
  • K993469 — WAKO L-TYPE UA F TEST (November 9, 1999)
  • K991247 — URIC ACID, MODEL UA112-01 (May 25, 1999)

FDA data resources