Home / 510(k) Clearances / K023550

510(k) K023550

WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA by Wiener Laboratories Saic — Product Code KNK

K023550 is an FDA 510(k) premarket notification submitted by Wiener Laboratories Saic for the device "WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA". The FDA issued a decision of Substantially Equivalent on December 9, 2002. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Wiener Laboratories Saic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2002
Date Received
October 22, 2002
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 Wiener Laboratories Saic

  • K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 (February 11, 2004)
  • K024305 — WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 (March 18, 2003)
  • K024116 — WIENER LAB. BILIRUBINA DIRECT AA (February 12, 2003)
  • K023992 — WIENER LAB COLINESTERASA AA (February 12, 2003)
  • K023744 — WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 (January 3, 2003)
  • K023551 — WIENER LAB GOT (AST) UV AA LIQUIDA (December 9, 2002)
  • K023549 — WIENER LAB AMILASA 405 AA LIQUIDA (December 9, 2002)
  • K022962 — WIENER LAB. BILIRRUBINA TOTAL AA (November 1, 2002)
  • K021334 — WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB. (September 10, 2002)
  • K021332 — WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV A (July 3, 2002)

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)
  • 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)
  • K981604 — CARESIDE URIC ACID (June 25, 1998)

FDA data resources